System and method for syringe fluid fill verification and image recognition of power injector system features

ABSTRACT

A fluid injection system and a fluid verification system for confirming that a syringe, containing a fluid for injection, is fully filled with fluid and neither has free space (i.e., air) near the distal end thereof when the syringe is provided in an upright position nor contains air bubbles. Imaging processing techniques and systems are also provided to determine various injection parameters and to verify the type and certain properties of fluid that is present within a syringe.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Divisional Application of U.S. application Ser.No. 15/249,667, filed Aug. 29, 2016, now U.S. Pat. No. 10,420,902,issued Sep. 24, 2019 and which claims priority to United StatesProvisional Patent Application Ser. Nos. 62/211,462, entitled “Systemand Method for Syringe Fluid Fill Verification and Image Recognition ofPower Injector System Features”, filed Aug. 28, 2015 and 62/259,824,entitled “System and Method for Syringe Fluid Fill Verification andImage Recognition of Power Injector System Features”, filed Nov. 25,2015, the contents of each of which are incorporated herein byreference.

BACKGROUND OF THE DISCLOSURE Field

The present disclosure relates to systems and methods for verifying thata syringe is filled with fluid and, in particular, for determining thepresence of such fluid based on an illuminated pattern produced byelectromagnetic radiation projected through a portion of the filledsyringe. In other aspects, the present disclosure relates to systems andmethods for identifying the various features and properties of the fluidwithin the syringe.

Description of Related Art

In many medical, diagnostic, and therapeutic procedures, a medicalpractitioner, such as a physician, injects a patient with a medicalfluid. In recent years, a number of injector-actuated syringes andpowered injectors for pressurized injection of fluids, such as contrastmedia (often referred to simply as “contrast”), medicaments, or saline,have been developed for use in imaging procedures such as angiography,computed tomography, ultrasound, and magnetic resonance imaging. Ingeneral, these powered injectors are designed to deliver a preset amountof contrast or other fluid at a preset flow rate.

One of the issues involved in the injection of fluids into a patientusing such automated injector systems is the possibility that air may bepresent in the syringe or fluid delivery system prior to injection. Thisissue is of particular concern in injection procedures for contrastmedium, which are frequently colorless or only tinted to a limiteddegree. Further, imaging procedures are often performed under relativelylow light levels to facilitate reading of x-rays, computer displayscreens, and the like. Accordingly, the concern that air in the syringewill not be identified prior to the injection procedure is increased. Itis, therefore, desirable to readily detect if the syringe has not beenfilled with the fluid or is only partially filled with fluid (i.e., thesyringe contains an amount of air) prior to the attempted injection.

Some solutions have been previously provided, in which the presence ofliquid is indicated by an alteration of shape of an indicator pattern onthe barrel of the syringe, as discussed, for example, in U.S. Pat. No.4,452,251 to Heilman and U.S. Pat. No. 5,254,101 to Trombley, III, eachof which are incorporated by reference herein in their entireties.However, systems and methods are needed to further aid in indicating thepresence of liquid when the syringe is viewed from a distance or toallow verification of a filled syringe at a glance. Automated systemsfor verifying that the syringe is fully filled and does not include anyair are also desirable.

In addition, since most medical fluids used with power injectors areclear, it is very difficult for a technician to quickly and easilydistinguish between the fluid and air present in a translucent syringe.Accordingly, a need exists for a system used with a fluid injectiondevice that is capable of differentiating between air and differenttypes of fluid. In addition, automated systems that can determinevarious properties of the fluid, for example by analyzing propertiesand/or changes of the interaction between electromagnetic radiation withthe contents of the syringe, and communicating those properties to theuser, for example via a display screen, are also desirable.

SUMMARY

The systems and methods discussed herein provide an indication to theoperator of a fluid injector of the presence of liquid in a syringe whenthe syringe is viewed from a distance or to allow verification of afilled syringe at a glance. In addition, automated systems for verifyingthat the syringe is fully filled and does not include any air are alsoprovided. Such systems allow for the differentiation between air and/ordifferent types of fluids contained within a syringe of the fluidinjector, thereby enhancing safety by preventing air injections as wellas facilitating improved workflow by preventing technicians from mixingup the fluid types. Further, in certain aspects the system may determineone or more properties of the fluid within the syringe and/or theinjection procedure.

According to one aspect of the present disclosure, provided is a syringecomprising: a syringe barrel comprising a proximal end and a distal endcomprising an angled surface; and a plunger slideably disposed in thesyringe barrel and configured to advance through the barrel to expel afluid therefrom. The plunger comprises a transparent or translucentmaterial configured to transmit electromagnetic radiation therethroughsuch that an illuminated identification pattern is formed at apredetermined portion of the distal end of the syringe barrel when thesyringe is filled with the fluid.

In one aspect, the syringe barrel may be shaped such that when aninterior volume of the syringe barrel is completely or partially filledwith air, at least one property of the illuminated identificationpattern is different compared to when the syringe is completely filledwith the fluid. The at least one property may comprise at least one ofpresence of, size, shape, and brightness of the illuminatedidentification pattern.

In one aspect, the illuminated identification pattern may not be visiblewhen a percentage of a volume of air present in the distal end of thesyringe is greater than about 15% of the volume of the distal end of thesyringe having the angled surface. In another aspect, the illuminatedidentification pattern may be visible to an observer or to a sensor whenthe syringe is viewed from a side, at a straight-on orientation, or atilted forward or tilted backward orientation. The angled surface of thedistal end of the syringe barrel may have an angle of about 30 degreesto 60 degrees relative to a longitudinal axis of the syringe.

In one aspect, the electromagnetic radiation source may comprise a lightbulb, an LED bulb, a photon emitter, an infrared emitter, a laser, orambient light. In another aspect, at least one reference line or markingmay be formed on a distal end of the syringe barrel and extend around acircumference of the distal end of the syringe barrel. The at least onereference line or marking may be formed on the barrel of the syringe byat least one of printing, overmolding, and etching. In one aspect, afirst reference line or marking of the at least one reference line ormarking is configured to align with a first predetermined portion of theilluminated identification pattern if a first fluid is present withinthe syringe and a second reference line or marking is configured toalign with a second predetermined portion of the illuminatedidentification pattern if a second fluid is present within the syringe.The at least one reference line or marking may be configured to alignwith a predetermined portion of the illuminated identification patternif a first fluid is present within the syringe and may be configured tobe positioned away from the illuminated identification pattern if asecond fluid is present within the syringe.

According to another aspect of the present disclosure, provided is asystem for indicating whether a syringe is ready for use in injecting afluid therein into a patient. The system comprises: a syringe comprisinga barrel comprising a distal end having an angled surface and definingan interior volume configured to receive the fluid; and anelectromagnetic radiation source positioned to emit electromagneticradiation through at least a portion of the syringe. The syringe isshaped such that, when the syringe is filled with the fluid, at least aportion of the electromagnetic radiation is affected by an interactionof the electromagnetic radiation with at least one interface associatedwith the fluid and the syringe to form an illuminated identificationpattern indicative of contents of the syringe on a predetermined portionof the syringe.

In one aspect, the syringe may be shaped such that when the interiorvolume is completely or partially filled with air, at least one propertyof the illuminated identification pattern is different compared to whenthe interior volume is completely filled with the fluid. The at leastone property may comprise at least one of presence of, size, shape, andbrightness of the illuminated identification pattern. The illuminatedidentification pattern may not be visible when a percentage of a volumeof air present in the distal end of the syringe is greater than about15% of the volume of the distal end of the syringe having the angledsurface.

In another aspect, the system may further include at least one sensorconfigured to measure the at least one property of the illuminatedidentification pattern when present. The at least one sensor maycomprise at least one of an imaging sensor, an optical sensor, anelectromagnetic radiation detector, or a digital camera. In anotheraspect, the system may also include a fluid injector configured tointerface with the syringe to eject the fluid from the syringe. Thefluid injector may comprise a controller configured to receive aconfirmation signal from the at least one sensor when the measurement ofthe at least one property of the illuminated identification patternindicates that the syringe is substantially filled with fluid, and thecontroller is configured to actuate the injector to perform an injectionwhen the confirmation signal is received.

In one aspect, the illuminated identification pattern may be visible toan observer or to a sensor when the syringe is viewed from a side, at astraight-on orientation, or at a tilted forward or tilted backwardorientation. In another aspect, the illuminated identification patternmay comprise an annular shape extending about at least a portion of thedistal end of the syringe barrel. In yet another aspect, the angledsurface of the distal end of the barrel may have an angle of about 30degrees to 60 degrees relative to a longitudinal axis of the syringe. Inone aspect, the electromagnetic radiation source may comprise a lightbulb, an LED bulb, a photon emitter, an infrared emitter, a laser, orambient light.

In certain aspects, the syringe may further comprise a plunger, and theelectromagnetic radiation source is positioned to project at least aportion of the electromagnetic radiation to reflect off or transmitthrough the plunger. In one example, at least a portion of the plungercomprises a transparent or translucent material. In another example, atleast a portion of the plunger comprises a colored material.

According to another aspect of the present disclosure, provided is amethod for syringe fluid fill verification comprising: emittingelectromagnetic radiation through at least a portion of a syringe;identifying whether at least a portion of the electromagnetic radiationproduces an illuminated identification pattern on a predeterminedportion of the syringe; and determining contents of the syringe based onat least one property of the illuminated identification pattern.

In one aspect, the at least one property may be at least one of apresence of the illuminated identification pattern, a size of theilluminated identification pattern, a shape of the illuminatedidentification pattern, and a brightness of the illuminatedidentification pattern. In another aspect, the step of: identifyingwhether the at least a portion of the electromagnetic radiation producesan illuminated identification pattern may comprise: measuring the atleast one property of the illuminated identification pattern by at leastone sensor associated with the syringe; and receiving a confirmationsignal from the at least one sensor indicating a value for the at leastone property of the illuminated identification pattern. In an additionalaspect, emitting electromagnetic radiation through at least the portionof the syringe may comprises emitting electromagnetic radiation througha syringe plunger, at least a portion of which comprises a transparentor translucent material.

According to another aspect of the present disclosure, provided is afluid injection system that comprises: a fluid injector; at least onesyringe operatively engaged with the fluid injector; and anelectromagnetic radiation source. The at least one syringe comprises abarrel comprising a distal end having an angled surface and defining aninterior volume configured to receive a fluid. The electromagneticradiation source is positioned relative to the at least one syringe toemit electromagnetic radiation through at least a portion of the atleast one syringe such that, when the syringe is filled with the fluid,at least a portion of the electromagnetic radiation is affected by aninteraction of the electromagnetic radiation with at least one interfaceassociated with the fluid and the syringe to form an illuminatedidentification pattern indicative of contents of the at least onesyringe on a predetermined portion of the at least one syringe. Thefluid injection system also comprises: an image capture devicepositioned to capture an image of the illuminated identificationpattern; and at least one computing device in communication with theimage capture device and the fluid injector. The at least one computingdevice comprises at least one processor configured to: determine adistance from a bottom to a top of the illuminated identificationpattern in the image of the illuminated identification pattern; comparethe distance from the bottom to the top of the illuminatedidentification pattern to at least one predetermined distance; and basedon the comparison of the distance from the bottom to the top of theilluminated identification pattern to the at least one predetermineddistance, at least one of i) display on a display device incommunication with the at least one processor an indication of acharacteristic of the at least one syringe; ii) enable the fluidinjector to perform a function; and iii) disable the fluid injector fromperforming an action.

In one aspect, determining a distance from the bottom to the top of theilluminated identification pattern may comprise determining a bottomedge of the illuminated identification pattern and determining a topedge of the illuminated identification pattern. The bottom edge and thetop edge of the illuminated identification pattern may be determined bydetermining a change in contrast between neighboring pixels in the imageof the illuminated identification pattern.

In another aspect, the characteristic of the at least one syringe may bethe presence of air in the at least one syringe and the at least oneprocessor may be further configured to, if the distance from the bottomto the top of the illuminated identification pattern is less than the atleast one predetermined distance, provide an indication that air ispresent in the at least one syringe and disable the fluid injector fromconducting an injection procedure. In addition, the at least oneprocessor may be configured to determine a size of the at least onesyringe prior to determining the distance from the bottom to the top ofthe illuminated identification pattern by matching a first template of aknown illuminated identification pattern for a syringe having a firstsize with the image of the illuminated identification pattern. In oneaspect, the at least one processor may be further configured to providean indication that the at least one syringe has the first size if thefirst template matches the image of the illuminated identificationpattern. The at least one processor may be further configured to match asecond template of a known illuminated identification pattern for asyringe having a second size with the image of the illuminatedidentification pattern if the first template does not match the image ofthe illuminated identification pattern. The at least one processor maybe further configured to provide an indication that the at least onesyringe has the second size if the second template matches the image ofthe illuminated identification pattern.

In another aspect, the characteristic of the at least one syringe may becontents of the at least one syringe. The at least one predetermineddistance may comprise a first predetermined distance indicative of afirst fluid as the contents contained in the at least one syringe and asecond predetermined distance indicative of a second fluid as thecontents contained within the at least one syringe. If the distance fromthe bottom to the top of the illuminated identification patterncorresponds to the first predetermined distance, an indication that thefirst fluid is contained in the at least one syringe may be provided,and, if the distance from the bottom to the top of the illuminatedidentification pattern corresponds to the second predetermined distance,an indication that the second fluid is contained in the at least onesyringe may be provided. If the at least one processor determines thatthe first fluid is present in the at least one syringe, a color of theelectromagnetic radiation forming the illuminated identification patternmay be set to a first color and, if the at least one processordetermines that the second fluid is present in the at least one syringe,the color of the electromagnetic radiation forming the illuminatedidentification pattern may be set to a second color different from thefirst color.

In other aspects, the at least one syringe may further comprise aplunger, and the electromagnetic radiation source may be positioned toproject at least some of the electromagnetic radiation through theplunger. In such aspects, the plunger may comprise a transparent ortranslucent material. In still other aspects, the electromagneticradiation source may be positioned such that the electromagneticradiation reflects from a distal surface of the plunger through thebarrel. In such aspects, the plunger may comprise an opaque, coloredmaterial. In other aspects, the electromagnetic radiation source may bepositioned adjacent to the barrel of the at least one syringe and theelectromagnetic radiation is reflected from a mirror located near thedistal end of the barrel and directed toward a distal surface of theplunger such that the electromagnetic radiation reflects from theplunger through the barrel.

According to an additional aspect of the present disclosure, provided isa fluid injection system comprising: a fluid injector; at least onesyringe operatively engaged with the fluid injector, the syringecomprising a barrel comprising a distal end having an angled surface anddefining an interior volume configured to receive the fluid; anelectromagnetic radiation source positioned relative to the at least onesyringe to emit electromagnetic radiation through at least a portion ofthe at least one syringe such that, when the syringe is filled with thefluid, at least a portion of the electromagnetic radiation is affectedby an interaction of the electromagnetic radiation with at least oneinterface associated with the fluid and the syringe to form anilluminated identification pattern indicative of contents of the atleast one syringe on a predetermined portion of the at least onesyringe; an image capture device positioned to capture an image of theilluminated identification pattern; and at least one computing device incommunication with the fluid injector and the image capture device. Theat least one computing device comprises at least one processorconfigured to: determine a distance from a bottom to a top of theilluminated identification pattern in the image of the illuminatedidentification pattern; compare the distance from the bottom to the topof the illuminated identification pattern to a predetermined distance;and if the distance from the bottom to the top of the illuminatedidentification pattern is less than the predetermined distance, providean indication that air is present in the at least one syringe anddisable the fluid injector from conducting an injection procedure.

In one aspect, determining a distance from the bottom to the top of theilluminated identification pattern may comprise determining a bottomedge of the illuminated identification pattern and determining a topedge of the illuminated identification pattern. The bottom edge and thetop edge of the illuminated identification pattern may be determined bydetermining a change in contrast between neighboring pixels in the imageof the illuminated identification pattern.

In another aspect, the at least one processor may be configured todetermine a size of the at least one syringe prior to determining thedistance from the bottom to the top of the illuminated identificationpattern by matching a first template of a known illuminatedidentification pattern for a syringe having a first size with the imageof the illuminated identification pattern. The at least one processormay be further configured to provide an indication that the at least onesyringe has the first size if the first template matches the image ofthe illuminated identification pattern. The at least one processor maybe further configured to match a second template of a known illuminatedidentification pattern for a syringe having a second size with the imageof the illuminated identification pattern if the first template does notmatch the image of the illuminated identification pattern. The at leastone processor may be further configured to provide an indication thatthe at least one syringe has the second size if the second templatematches the image of the illuminated identification pattern.

According to another aspect of the present disclosure, provided is afluid injection system that comprises: a fluid injector; at least onesyringe operatively engaged with the fluid injector and configured to beilluminated with an electromagnetic radiation source to illuminate fluidcontained therein; a sensor positioned to capture an image of theilluminated fluid; and at least one computing device in communicationwith the fluid injector and the sensor. The at least one computingdevice comprises at least one processor configured to: obtain from thesensor the image of the illuminated fluid; determine, based on the imageof the illuminated fluid, at least one of: a type of the fluid containedwithin the at least one syringe; and whether air is contained within theat least one syringe; and automatically display on a display device incommunication with the at least one processor one of: an indication ofthe type of the fluid contained within the at least one syringe; and anindication that air is contained within the at least one syringe.

In certain aspects, the at least one processor may be configured todisable the fluid injector from conducting an injection procedure if airis determined to be contained within the at least one syringe.Brightness measurements may be performed in a region of interest in theimage of the illuminated fluid are utilized to determine at least oneof: type of fluid contained within the at least one syringe; and whetherair is contained within the at least one syringe.

According to another aspect of the present disclosure, provided is afluid injection system comprising: a fluid injector; a syringeoperatively engaged with the fluid injector; an image capture device;and at least one computing device in communication with the fluidinjector and the image capture device. The syringe comprises a barreland defining an interior volume and at least one feature provided on thebarrel of the syringe. The at least one feature has a differentappearance when viewed through different types of fluid contained withinthe syringe. The image capture device is positioned to capture an imageof the at least one feature through a content of the syringe. The atleast one computing device comprises at least one processor configuredto: obtain the image of the at least one feature through the fluidcontained within the syringe; determine, based on the image of the atleast one feature, an appearance of the at least one feature; comparethe determined appearance with templates of appearances of the at leastone feature when viewed through different types of fluids; andautomatically display on a display device in communication with the atleast one processor an indication of a characteristic of the syringebased on the comparison.

In one aspect, the at least one feature may be formed on the barrel ofthe syringe by at least one of printing, overmolding, and etching. Inanother aspect, the at least one feature may be a fluid dot, a line, aseries of lines, or any combination thereof. The appearance of the atleast one feature may comprise at least one of a shape of the at leastone feature and an orientation of the at least one feature.

In one aspect, the characteristic of the syringe may be the presence ofair in the syringe and the at least one processor may be furtherconfigured to, if the determined appearance matches one of the templatesof appearances of the at least one feature when viewed through air,provide an indication that air is present in the at least one syringeand disable the fluid injector from conducting an injection procedure.

In another aspect, the characteristic of the at least one syringe may bethe contents of the at least one syringe and the at least one processormay be further configured to, if the determined appearance matches oneof the templates of appearances of the at least one feature when viewedthrough a first fluid, provide an indication that the first fluid ispresent within the syringe. In one aspect, the at least one processormay be further configured to, if the determined appearance matches oneof the templates of appearances of the at least one feature when viewedthrough a second fluid, provide an indication that the second fluid ispresent within the syringe.

According to another aspect of the present disclosure, provided is afluid injection system comprising: a fluid injector; a syringeoperatively engaged with the fluid injector in a vertical orientation,the syringe comprising a barrel and defining an interior volumeconfigured to receive a fluid and at least one object having a densitythat is different than the density of the fluid such that the at leastone object floats if the fluid is present within the barrel; an imagecapture device positioned to capture an image of the barrel; and atleast one computing device in communication with the fluid injector andthe image capture device. The at least one computing device comprises atleast one processor configured to: obtain the image of the barrel;determine, based on the image of the barrel, a position of the at leastone object within the barrel and thus whether the barrel is one of (i)filled completely with the fluid and (ii) filled at least partially withair; provide an indication, based on the determination, that air ispresent in the syringe based on the position of the at least one object;and disable the fluid injector from conducting an injection procedure.

According to still another aspect of the present disclosure, provided isa fluid injection system comprising: a fluid injector; a syringeoperatively engaged with the fluid injector; an image capture devicepositioned to capture an image of at least a portion of the syringe; andat least one computing device in communication with the fluid injectorand the image capture device. The at least one computing devicecomprises at least one processor configured to: obtain the image of atleast a portion of the syringe; determine, based on at least a portionof the syringe, at least one characteristic of an injection procedureperformed by the fluid injector; and adjust the at least onecharacteristic of the injection procedure performed by the fluidinjector to ensure that fluid is delivered to a predetermined region ofinterest in a body of a patient at a particular time such that viableimages are produced during an imaging procedure.

In one aspect, the at least one characteristic of the injectionprocedure may be at least one of flow rate, volume of fluid remainingwithin the syringe, and capacitance measurement of the syringe.

These and other features and characteristics of the systems and/ordevices of the present disclosure, as well as the methods of operationand functions of the related elements of structures and the combinationof parts and economies of manufacture, will become more apparent uponconsideration of the following description and the appended claims withreference to the accompanying drawings, all of which form a part of thisspecification, wherein like reference numerals designate correspondingparts in the various figures. It is to be expressly understood, however,that the drawings are for the purpose of illustration and descriptiononly and are not intended as a definition of the limits of the systemsand/or devices of the present disclosure. As used in the specificationand claims, the singular form of “a”, “an”, and “the” include pluralreferents unless the context clearly dictates otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic drawing of a fluid injector and fluid verificationsystem, according to an aspect of the disclosure;

FIG. 2 is a schematic drawing of a syringe according to an aspect of thedisclosure for use with the injector of FIG. 1;

FIGS. 3A-3D are schematic drawings of syringes having various shapeddistal ends along with the appearance of an illuminated identificationpattern, according to an aspect of the present disclosure;

FIGS. 4A-4C are schematic drawings of syringes having various featuresprovided on a distal end thereof to change shape and/or size of theilluminated identification pattern;

FIGS. 5A and 5B are perspective and schematic views, respectively, of asyringe plunger that may be utilized with the syringe of FIG. 2;

FIG. 6 is a schematic drawing of a syringe and fluid verification systemincluding a backlit plunger, according to an aspect of the disclosure;

FIG. 7 is a schematic drawing of a syringe that is completely orpartially filled with air in use with the fluid verification system ofFIG. 6;

FIG. 8 is a schematic drawing of a fluid filled syringe in use with thefluid verification system of FIG. 6;

FIG. 9 is a schematic drawing of another example of a syringe and fluidverification system with a backlit plunger, according to an aspect ofthe disclosure;

FIG. 10 is a schematic drawing of a syringe and fluid verificationsystem with a reflective plunger;

FIG. 11 is a schematic drawing of another embodiment of a syringe andfluid verification system with a reflective plunger;

FIG. 12 is a schematic drawing of another embodiment of a syringe andfluid verification system with a reflective plunger and fiber opticlight pipe;

FIG. 13 is a schematic drawing showing light rays reflecting within andtransmitting through a fluid filled syringe barrel according to anaspect of the disclosure;

FIGS. 14A-14C are schematic drawings of portions of the distal end ofembodiments of a fluid filled syringe for use with a fluid verificationsystem, according to aspects of the disclosure;

FIG. 15A is a side view of a rolling diaphragm syringe in accordancewith one aspect of the present disclosure;

FIG. 15B is a cross-sectional side view of the rolling diaphragm syringeshown in FIG. 15A taken along line A-A;

FIG. 16A is a perspective view of a rolling diaphragm syringe and apressure jacket in accordance with another aspect of the presentdisclosure;

FIG. 16B is a cross-sectional side view of the rolling diaphragm syringeand the pressure jacket shown in FIG. 16A;

FIG. 16C is a perspective view of a rolling diaphragm syringe and a capfor use with the pressure jacket shown in FIG. 16A;

FIGS. 17A and 17B are a perspective cross-sectional view andcross-sectional view of the rolling diaphragm syringe and portions of anengagement mechanism illustrating a first configuration of anelectromagnetic radiation source, according to an aspect of thedisclosure;

FIGS. 18A and 18B are perspective cross-sectional views of the rollingdiaphragm syringe and portions of an engagement mechanism illustratingsecond and third configurations of an electromagnetic radiation source,according to aspects of the disclosure;

FIGS. 19A and 19B are a perspective cross-sectional view andcross-sectional view of a rolling diaphragm syringe and portions of anengagement mechanism illustrating a third configuration of anelectromagnetic radiation source, according to aspects of thedisclosure;

FIG. 20 is a cross-sectional view of the rolling diaphragm syringe andportions of the engagement mechanism illustrating a protruding element,according to an aspect of the disclosure;

FIG. 21 is a flow chart of a method for determining presence of airwithin a syringe utilizing image processing techniques in accordancewith an aspect of the present disclosure;

FIGS. 22 and 23 are drawings of exemplary images of a distal end of asyringe used in the method of FIG. 21;

FIG. 24 is a graph illustrating the correlation between the presence ofair and the size of the distance between the meniscus and the halo usedin the method of FIG. 21

FIG. 25 is a schematic drawing of an alternative syringe for use withthe injector of FIG. 1;

FIG. 26 is a flow chart of an alternative method for determining thepresence of air within a syringe utilizing image processing techniquesand the syringe of FIG. 25 in accordance with an aspect of the presentdisclosure;

FIG. 27 is a drawing of an exemplary image of a distal end of a syringecontaining air used in the method of FIG. 26;

FIG. 28 is a drawing of an exemplary image used by an image recognitionsystem to determine whether air is present within a syringe usingbrightness measurements in accordance with an aspect of the presentdisclosure;

FIGS. 29 and 30 are drawings of exemplary images used by an imagerecognition system to determine the type of fluid contained within asyringe in accordance with an aspect of the present disclosure;

FIGS. 31 and 32 are drawings of alternative exemplary images used by animage recognition system to determine the type of fluid contained withina syringe in accordance with an aspect of the present disclosure;

FIGS. 33 and 34 are drawings of exemplary images used by an imagerecognition system to determine the size of a syringe in accordance withaspects of the present disclosure;

FIGS. 35 and 36 are drawings of exemplary images used by an imagerecognition system to determine whether a fluid path set is connected toa syringe in accordance with an aspect of the present disclosure;

FIG. 37 is a perspective view of a fluid transfer system including afluid transfer device for transferring fluid from a fluid container intoa syringe in accordance with an aspect of the present disclosure;

FIGS. 38 and 39 are drawings of exemplary images used by an imagerecognition system to determine whether a fluid transfer device isconnected to a syringe in accordance with an aspect of the presentdisclosure;

FIG. 40 is a perspective view of a purge container connected to a fluidtransfer set in accordance with an aspect of the present disclosure;

FIG. 41 is a perspective view of the purge container of FIG. 40;

FIG. 42A is a front plan view of the purge container of FIG. 40 with nofluid contained therein;

FIG. 42B is a front plan view of the purge container of FIG. 40 withfluid contained therein;

FIG. 43A is a perspective view of an alternative configuration of thepurge container of FIG. 40 with no fluid contained therein;

FIG. 43B is a front plan view of the purge container of FIG. 43A withfluid contained therein;

FIG. 44A is a perspective view of another alternative configuration ofthe purge container of FIG. 40 with no fluid contained therein;

FIG. 44B is a front plan view of the purge container of FIG. 44A withfluid contained therein;

FIG. 45 is a perspective view of an example of a purge containerconnected to a fluid transfer set in accordance with an aspect of thepresent disclosure;

FIG. 46 is a front view of an end of tubing used with the fluid transferset in accordance with an aspect of the present disclosure;

FIG. 47 is a schematic view of a syringe during an injection procedureillustrating the manner in which the syringe stretches and swells inaccordance with an aspect of the present disclosure;

FIG. 48 is a graph illustrating volume delivered versus time during anexemplary injection procedure;

FIG. 49 is a flow chart of a method for determining the volume of fluidremaining within a syringe utilizing image processing techniques inaccordance with an aspect of the present disclosure;

FIG. 50 is a perspective view of an alternative syringe for use with thesystem of FIG. 1;

FIG. 51 is a side view of the syringe of FIG. 50;

FIG. 52 is a schematic view of the syringe of FIG. 50 delivering fluidat low pressure and a fluid verification system in accordance withaspects of the present disclosure;

FIG. 53 is a schematic view of the syringe of FIG. 50 delivering fluidat high pressure and a fluid verification system in accordance withaspects of the present disclosure;

FIG. 54 is a schematic view of the syringe of FIG. 50 drawing in fluidat negative pressure in accordance with an aspect of the presentdisclosure;

FIG. 55 is a schematic view of the syringe of FIG. 15A having a pressureindicating mechanism associated therewith in accordance with an aspectof the present disclosure;

FIG. 56A is a schematic view of a syringe delivering fluid at lowpressure and a fluid verification system in accordance with anotheraspect of the present disclosure;

FIG. 56B is a schematic view of the syringe of FIG. 56A delivering fluidat high pressure and the fluid verification system;

FIG. 57 is a schematic view of a syringe having a temperature stripincorporated therewith in accordance with an aspect of the presentdisclosure;

FIG. 58 is a front perspective view of a fluid injection system inaccordance with an aspect of the present disclosure;

FIG. 59 is a schematic view of the fluid injection system in accordancewith an aspect of the present disclosure;

FIG. 60 is a schematic view of a portion of the fluid injector of thefluid injection system of FIG. 59;

FIGS. 61-63 are schematic views of various configurations of the fluidinjection system of FIG. 59;

FIG. 64 is a schematic view of another alternative syringe for use withthe system of FIG. 1;

FIG. 65 is a schematic view of the syringe of FIG. 64 filled with airand a fluid verification system in accordance with an aspect of thepresent disclosure;

FIG. 66 is a schematic view of the syringe of FIG. 64 filled with salineand a fluid verification system in accordance with an aspect of thepresent disclosure; and

FIG. 67 is a schematic view of the syringe of FIG. 64 filled withcontrast and a fluid verification system in accordance with an aspect ofthe present disclosure.

DESCRIPTION

For purposes of the description herein, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the disclosureas it is oriented in the drawing figures. When used in relation to asyringe, the term “proximal” refers to the portion of a syringe nearestto an injector, when a syringe is connected to an injector. The term“distal” refers to the portion of a syringe farthest away from aninjector. It is to be understood, however, that the disclosure mayassume alternative variations and step sequences, except where expresslyspecified to the contrary. It is also to be understood that the specificdevices and processes illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the disclosure. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

One aspect of the present disclosure is directed to a fluid injectionsystem and a fluid verification system for confirming, using imageprocessing techniques, that a syringe, containing a fluid for injection,is fully filled with fluid and neither has free space (i.e., air) nearthe distal end thereof when the syringe is provided in an uprightposition nor contains air bubbles. The present disclosure is alsogenerally directed to using imaging processing techniques to determinevarious injection parameters to verify the type and certain propertiesof fluid that is present within a syringe.

As used herein, fluid and/or medical fluid refer to liquid substances orsolutions, such as, but not limited to, contrast, saline, andtherapeutic liquids. In certain aspects, the fluid verification systemis configured to emit electromagnetic radiation, such as a visible orinfrared light, through at least a portion of the syringe barrel.Electromagnetic radiation refers to radiant energy that propagatesthrough space in the form of one or more electromagnetic waves.Electromagnetic radiation can be visible (e.g. having a wavelength ofbetween approximately 400 nm to 700 nm) or non-visible to the human eye,as is the case, for example, with x-rays, radio rays, infraredradiation, and ultraviolet radiation. In addition, as used hereinelectromagnetic radiation may be ambient light. When the syringe isfully filled with a fluid, the electromagnetic radiation is refracted bythe fluid and/or the syringe barrel to illuminate the distal end of thesyringe to provide a distinctive identification pattern. The illuminatedarea defining the identification pattern on the distal end of thesyringe is referred to herein as a halo. As used herein the term “halo”includes an illuminated identification pattern that includes a circularcolored/illuminated ring around or a conical sub-portion of the distalportion of the conical distal end of the syringe. This halo may bereadily identified by an operator when viewed at a straight-on, trueside view, or slightly elevated position. In one example, thisstraight-on or true side view may be in a plane generally parallel to aplane extending through a central axis of the syringe and generallyalong a plane extending through a distal end of the syringe.Illuminating the syringe in the manner described herein may also causeany air bubbles present along the sidewalls of the syringe barrel to beilluminated, thereby allowing an operator or sensor to more easilyidentify the presence of such air bubbles.

In some aspects, one or more sensors may be configured to capture imagesof the distal end of the syringe, for example to detect the halo patternvia automated image processing techniques. If the syringe is entirelyfilled with fluid, a distinctly observable halo, for example in a formof a lighted band on at least a portion of the distal end of thesyringe, is illuminated as an identification that the syringe is fullyfilled with fluid. If the syringe is not entirely filled with fluid,such as when the syringe is completely or partially filled with air, thesize and/or brightness of the halo is substantially reduced ordisappears. As used herein, fluid refers to a medical grade liquidconfigured to be delivered to a patient, such as saline or various typesand concentrations of contrast, as opposed to air or other gases.

I. Generation of Illuminated Identification Pattern

A. Exemplary Fluid Injection System

With reference to FIG. 1, a fluid injector 10, such as an automated orpowered fluid injector, is illustrated, which is adapted to interfacewith and actuate one or more syringes 12, which may be filed with afluid F, such as contrast media, saline solution, or any desired medicalfluid. The fluid injector 10 can be used during an angiographic,computed tomography (CT), magnetic resonance imaging (MRI), molecularimaging, or other medical procedure to inject contrast and/or a commonflushing agent, such as saline, into the body of a patient. In someexamples, the fluid injector 10 can be at least a dual-syringe injector,wherein the two fluid delivery syringes 12 are oriented in aside-by-side or other spatial relationship and are separately actuatedby respective linear actuators or piston elements associated with theinjector 10.

The injector 10 can be enclosed within a housing 14 formed from asuitable structural material, such as plastic and/or metal. The housing14 can be formed in various shapes and sizes depending on the desiredapplication. For example, the injector 10 can be a free-standingstructure configured to be placed on the floor or may be configured forplacement on a suitable table or support frame. The injector 10 includesone or more syringe ports 16 for connecting to the proximal ends of theone or more syringes 12 and to connect plungers 26 to respective pistonelements. The syringe ports 16 are generally located on a side of thehousing 14, as shown, for example, in FIG. 1. The housing 14 can berotatable to direct the syringe port 16 and syringe 12 extendingtherefrom in the vertical, horizontal, or downward facing direction. Insome examples, the syringe 12 can include at least one identificationtag 34, such as a label or bar code, including information about thesyringe dimensions, volume, pressure tolerances, and/or informationabout the fluid contained in the syringe 12. The at least oneidentification tag 34 can be read by a sensor 36, positioned on orrecessed in the side of the housing 14 or within at least a portion ofthe inner surface of the at least one syringe port 16 of the injector10.

A fluid path set 17 can be interfaced with the syringe 12 for deliveringone or more fluids from the syringe 12 to a catheter (not shown)inserted into a patient at a vascular access site. For example, a flowof saline solution from a first syringe 12 and contrast from a secondsyringe 12 may be regulated by a fluid control module (not shown)associated with the injector 10. The fluid control module operablycontrols injection rates, pressures, valves and flow regulatingstructures, such as pistons or linear actuators, to regulate thedelivery of the saline solution and/or contrast to the patient based onuser selected injection parameters, such as injection flow rate,duration, total injection volume, and ratio of contrast media andsaline, which may be programmed or otherwise entered into the injectorfluid control module.

A suitable front-loading fluid injector for use with the above-describedsystem is disclosed in U.S. Pat. No. 5,383,858 to Reilly et al., whichis incorporated by reference in its entirety. Other exemplarymulti-fluid delivery systems and components are found in U.S. Pat. No.7,553,294 to Lazzaro et al.; U.S. Pat. Nos. 7,666,169 and 9,199,033 toCowan et al.; U.S. Pat. No. 9,173,995 to Tucker et al.; PCT PublicationNo. WO 2012/155035 to Shearer et al.; and U.S. Patent ApplicationPublication No. 2014/0027009 to Riley et al., all of which are assignedto the assignee of the present application, and the disclosures of whichare incorporated herein by reference.

B. Exemplary Syringe for Use with the Fluid Injection Device

1. Details of Syringe Body

Having described the general structure and function of the fluidinjector 10, a syringe 12 configured for connection to the injector 10and containing a fluid F will now be discussed in detail. With referenceto FIG. 2, the syringe 12 comprises a substantially cylindrical barrel18 formed from glass or a suitable medical-grade plastic and defining aninterior volume 19. For example, the barrel 18 can be formed frommedical grade polyethylene terephthalate (PET) or other medical-gradeplastic material. The barrel 18 has a proximal end 20 and a tapered,conical distal end 24 extending to a nozzle 22. The barrel 18 can beformed from a transparent or translucent material so that a user orsystem operator can observe fluid F contained therein and, as isdiscussed herein, when used with a fluid verification system, canidentify the halo on the distal end 24 of the barrel 18. In otherexamples, only the distal end 24 of the barrel 18 is transparent ortranslucent, and other portions of the barrel 18 are formed from anopaque reflective material for increasing transmission of light throughthe barrel 18. In some aspects, a shield (not shown) may be providedaround an outer circumference of the barrel 18. The shield may be formedfrom an opaque reflective material for increasing the transmission oflight through the barrel 18. The fluid F generally has an index ofrefraction greater than that of air and may be different from thematerial of the barrel 18 and, therefore, alters the path ofelectromagnetic radiation, such as visible light, traveling through thebarrel 18 of the syringe 12. For example, the refractive index of air isabout 1, the refractive index of saline is about 1.34, the refractiveindex of contrast is about 1.46, and the refractive index of PET isabout 1.57. Without intending to be bound by theory, a travel path ofelectromagnetic radiation is governed by the reflection and refractioncharacteristics of the media through which electromagnetic radiationtravels.

The appearance of an illuminated area or halo 120 is determined, atleast in part, based on the angle and/or shape of the tapered distal end24 of the barrel 18 as shown in FIGS. 3A-3D. In some aspects, thetapered distal end 24 of the barrel 18 may be tapered at an angleranging from 30 degrees to 60 degrees, and in other aspects from 40degrees to 50 degrees relative to the horizontal or to a latitudinal orradial axis extending through the syringe 12. In one example, the angleof the tapered distal end 24 of the barrel 18 is about 45 degreesrelative to the horizontal (see FIG. 3A). There are also high and lowthresholds where the reflected illuminated area or halo no longerbecomes visible. Accordingly, changing the angle and/or shape of thetapered distal end 24 of the barrel 18 may have an impact on the sizeand visualization of the halo 120. For example, as the angle of thetapered distal end 24 of the barrel increases, the size of thevisualized halo increases (see FIG. 3C illustrating a syringe having atapered distal end 24 with an angle of 60 degrees relative to thehorizontal). However, the brightness of the halo generally decreaseswith such an increase of the angle. This may be compensated for byincreasing the intensity of the electromagnetic radiation from thesource used to generate the halo. In another example, as the angle ofthe tapered distal end 24 of the barrel 18 decreases, the size of thehalo 120 also decreases as shown in FIG. 3B. Finally, if the distal end24 of the syringe does not have any angled surfaces, such as the domeshaped syringe shown in FIG. 3D, no halo 120 is generated. The specificdetails of the manner in which the halo 120 is generated at the distalend of the syringe 12 are provided herein.

In some examples, at least a portion of the distal end 24 of the syringebarrel 18 can include one or more elements configured to accentuate theappearance of the halo 120. The one or more elements may be in the formof scallops or ridges 24A extending circumferentially around an outersurface of the distal end 24 of the barrel 18. The scallops or ridges24A can be positioned to refract at least a portion of the halo 120,making it visible over a range of viewing angles and user positions. Thescallops or ridges 24A can be used to make multi-part lenses such as aFresnel lens. Lenses of this type can allow light passing through theportion of the syringe 12 where the halo 120 is visualized to beredirected into a more direct path toward a detector or viewer. Suchlenses can also be used to transmit light over a farther distance andappear brighter at a larger number of viewing angles. Additionally, thescallops or ridges 24A allow for enhanced visualization of the halo 120or other features within the syringe 12. The geometry of the ridges 24Amay be determined by the internal reflection of the light and thecorresponding combination or convergence of rays back at the eye of theviewer. With reference to FIGS. 4A-4C, different arrangements of thescallops or ridges 24A at the distal end 24 leading to different shapesor sizes of the produced halo 120 are illustrated.

Returning to FIG. 2, in some examples, an annular flange, often referredto as a drip flange 28, extends radially outward from the syringe barrel18 at a position near the proximal end 20 thereof. When the syringe 12is inserted in the injector 10 (shown in FIG. 1), the drip flange 28 ispositioned relative to a distal opening of the syringe port 16 (shown inFIG. 1) to prevent excess fluid expelled from the syringe 12 fromentering the port 16. The portion of the syringe barrel 18 between thedrip flange 28 and the proximal end 20 of the barrel 18, referred toherein as the insertion portion 30, is sized and adapted to be insertedin the syringe port 16 of the injector 10. Accordingly, in someexamples, the insertion portion 30 of the barrel 18 includes one or morelocking structures, such as a locking flange 32, extending radiallyoutward from the barrel 18. The locking flange 32 can be adapted to forma locking engagement with corresponding protrusions or lockingstructures in syringe port 16 for releasably maintaining syringe 12 insyringe port 16 while injector 10 is in use. Alternatively, insertionportion 30 can include one or more latches, locking mechanisms, orradially extending ribs for connection to corresponding portions ofsyringe port 16.

Exemplary syringes suitable for use with the injector 10 depicted inFIG. 1, and which can be adopted for use with a fluid verificationsystem, are described in U.S. Pat. No. 5,383,858 to Reilly et al.; U.S.Pat. Nos. 7,666,169 and 9,199,033 to Cowan et al.; and U.S. Pat. No.9,173,995 to Tucker et al., which are assigned to the assignee of thepresent application. Additional exemplary syringes are disclosed in U.S.Pat. No. 6,322,535 to Hitchins et al. and U.S. Pat. No. 6,652,489 toTrocki et al., which are assigned to the assignee of the presentapplication. The disclosures of each of these references areincorporated by reference in their entireties.

2. Examples of Plungers for Use with Exemplary Syringe

With continued reference to FIG. 2, the proximal end 20 of the syringebarrel 18 can be sealed with a plunger or plunger cover 26 which isslidably disposed within the syringe barrel 18. The plunger or plungercover 26 may have a distal surface 26A. The plunger or plunger cover 26forms a liquid-tight seal against the sidewall of the barrel 18 as it isadvanced or withdrawn therethrough. The plunger or plunger cover 26 caninclude an interior cavity 27 and proximal opening 29 configured toreceive and engage a distal end of a piston rod (not shown) extendingfrom the injector 10 (shown in FIG. 1). The piston rod is advanced orretracted through the syringe barrel 18 by the injector 10 to drive theplunger or plunger cover 26 through the interior 19 of the syringebarrel 18 to expel fluid F therefrom or deliver fluid F into the syringebarrel 18.

In some examples, the plunger or plunger cover 26 is at least partiallyformed from a substantially transparent or translucent material andconfigured to permit electromagnetic radiation, such as visible light,ambient light, infrared light, or ultraviolet light, to pass through orbe emitted from a portion of the plunger or plunger cover 26. Forexample, the plunger or plunger cover 26 can include a transparent ortranslucent central portion enclosed by an annular elastomeric ring thatprovides the seal between the plunger cover 26 and the inner surface ofthe barrel 18. The emitted electromagnetic radiation radiates,propagates, or travels within and/or through the syringe barrel 18 in asubstantially axial direction toward the distal end 24 of the syringebarrel 18, while other electromagnetic radiation is emitted in anon-axial direction but at least a portion of the electromagneticradiation is reflected off of the interior surface of the syringe barrel18 toward the distal end 24. It also propagates from the plunger orplunger cover 26 in a non-axial direction with a portion thereofreflecting off the sidewall of the syringe barrel 18 toward the distalend 24 of the syringe 12. Electromagnetic radiation beams can bescattered when passing through the transparent or translucent materialof the plunger or plunger cover 26, which contributes to the appearanceof the halo. While the plunger or plunger cover 26 can be clear, ortinted white, certain more noticeable colors can be useful in particularapplications. For example, the plunger material can be tinted aconspicuous color, such as bright red or bright green, to impart a colorto the halo. Imparting a bright, noticeable color to the halo assiststhe system operator in recognizing the halo, when present. For example,the plunger or plunger cover 26 can be tinted green or blue to increasevisibility and as confirmation that the syringe 12 is ready for use(e.g., green is often understood to signify a “begin” or “go” state ofreadiness). Alternatively, the electromagnetic radiation passing throughthe plunger or plunger cover 26 may have a color, such as a red, green,blue, or other color from a light source to define a colored halo.

Alternatively, or in addition to including transparent or translucentportions, in other aspects the plunger or plunger cover 26 can includeone or more windows or openings 31 that permit the electromagneticradiation to pass therethrough. For example, the plunger or plungercover 26 can include a pattern of windows positioned along portions ofthe cover 26 that contributes to formation of the halo. The windows oropenings 31 can be covered by a transparent or translucent material orfilm to ensure that the plunger or plunger cover 26 is fluid tight.Other portions of the plunger or plunger cover 26 can be formed from anopaque material and, unlike in previously described examples, do notneed to be capable of allowing light to pass through. In one example,selective lighting through these windows or openings 31 can be used tochange patterns on the visible halo 120 or the color of the halo 120based on certain system conditions or states. For example, some of thewindows or openings 31 can be configured to have red light to emergetherethrough while other windows or openings 31 may be configured tohave yellow light to emerge therethrough. Accordingly, the halo 120 mayhave a red color if only the red lights are turned on, a yellow color ifonly the yellow lights are turned on, or an orange color if all of thelights are turned. A certain color of the halo 120 may provide anindication of the operation of certain system conditions or states suchas, but not limited to, the type of fluid being used, the size of thesyringe, the volume of fluid in the syringe, the pressure within thesyringe, the volume of fluid within the syringe, the presence of airwithin the syringe, etc.

In another example, the plunger or plunger cover 26 can be formed fromor coated with a reflective or colored material rather than atranslucent or transparent material. The reflective or colored materialor surface reflects light directed toward the plunger or plunger cover26 in the distal direction through the syringe barrel 18 to produce thehalo. Exemplary fluid verification systems including a reflectiveplunger are illustrated in FIGS. 10-12, which are discussed herein indetail.

In yet another example, as shown in FIGS. 5A and 5B, the plunger orplunger cover 26 can be formed from or coated with a reflective materialhaving a plurality of different colored stripes 38. The reflectivematerial forming the stripes 38 reflects light directed toward theplunger or plunger cover 26 in the distal direction through the syringebarrel 18 to produce the halo. As the plunger or plunger cover 26 movesthrough the barrel, light reflects from a different stripe 38 dependingon the position of the plunger or plunger cover 26 within the syringebarrel 18. Since each of the stripes 38 of the plunger or plunger cover26 are different in color, the color and/or appearance of the halochanges depending on the stripe 38 upon which the light is reflected asthe plunger or plunger cover 26 advances or retracts through the syringebarrel 18 during an injection or filing procedure. A sensor, such as animage capture device, can be positioned to capture images of the halo asthe plunger or plunger cover 26 advances or retracts through the syringebarrel 18 and detect the change in color of the halo. A processoroperatively coupled to the sensor and suitably programmed can then beused to determine the volume remaining within the syringe based on thecolor/appearance of the halo. While the example shown in FIGS. 5A and 5Bshows eight (8) different colored stripes, this is not to be construedas limiting the present invention as any suitable number of stripes maybe utilized. Alternatively, a plunger or plunger cover 26 may beconfigured to emit different colors of light at specific portions of thesyringe to produce a different colored halo depending on the volume offluid remaining in the syringe.

Additionally, patterns other than colored stripes could be used toencode information into the plunger in a way that it is viewed in thehalo 120. One example of such a pattern is a barcode. In other aspects,symbols and/or words may be printed or applied to the plunger surface tobe reflected to the halo portion and out to the user or imagerecognition means described herein. The process is similar to how acolored plunger creates a halo effect, however with symbols and/orletters in words, the reflection/refraction effect may slightly differ.For example, the syringe barrel represents a cylindrical lens with afocal point near the syringe tip. As an image approaches the focalpoint, the image may become distorted and stretched in ways which maymake it unrecognizable. Additionally, the image may become inverted anddifficult to read in the case of words. By controlling how the lightreflects within the barrel, for example utilizing a Fresnel lens effect,the light hitting the plunger can be controlled to a point source whichwill focus on the letters regardless of plunger position. Thus, letters,words and/or symbols can be written on the plunger and then transmittedto the user through the halo only when the syringe is full of fluid. Asdescribed herein, no effect would be observed if the syringe containedsignificant amounts of air. In another aspect, symbols, words, and/orletters may be used to differentiate between saline and contrast in thesyringe, as the letters or symbols written on the plunger will becomedistorted more significantly in contrast than in saline due todifferences in the refractive index.

C. Generating an Illuminated Identification Pattern with the ExemplarySyringe

Having generally described various aspects the structure of the syringe12 and plunger or plunger cover 26, with reference to FIG. 6, componentsof one example of a fluid verification system 110 will be discussed indetail. The fluid verification system 110 includes an electromagneticradiation source 112 for generating the radiation beam that forms a halo120. The electromagnetic radiation source 112 can be a light bulb, LEDbulb, visible light emitter, infrared emitter, laser, otherelectromagnetic radiation sources, or ambient light provided to projectan electromagnetic radiation beam through the interior 19 of the syringe12. In certain aspects, electromagnetic radiation source 112 emitselectromagnetic radiation generally in an axial direction throughsyringe barrel 18 towards the distal end of the syringe.

1. Electromagnetic Radiation Source Positioned Beneath the Plunger

For example, as shown in FIG. 6, an electromagnetic radiation beam Bpasses through the translucent or transparent plunger or plunger cover26 and toward the distal end 24 of the barrel 18. The electromagneticradiation source 112 can be configured to increase conspicuousness ofthe halo 120 or to tailor the halo 120 for particular sensors orelectromagnetic radiation detectors. In one example, the electromagneticradiation source 112 comprises a laser of a specific wavelength, forexample in one embodiment having a wavelength of about 532 nm (e.g., agreen laser). Lasers emitting electromagnetic radiation at otherwavelengths within the visible region are also envisioned. The laserelectromagnetic radiation source 112 can be used with neutral colored ortransparent plungers and still produce a conspicuous colored halo 120.In other examples, the electromagnetic radiation source 112 can emitelectromagnetic radiation outside the visible spectrum provided that thesystem includes a sensor or camera capable of detecting radiation (e.g.the halo 120) within the emitted wavelength. In still other examples,the electromagnetic radiation source 112 can emit polarized light orcertain wavelengths of filtered light, which can be more easilydistinguished from ambient light. In other examples, electromagneticradiation source 112 can be configured to emit pulses of light accordingto a predetermined and identifiable sequence, which can be identified bya system operator or automatically detected by a sensor.

With continued reference to FIG. 6, the electromagnetic radiation source112 is disposed below the plunger or plunger cover 26 to backlight theplunger or plunger cover 26. For example, LED bulbs or otherelectromagnetic radiation emitting devices can be mounted to a baseportion of a syringe-receiving stand, a piston, an actuator, or thesyringe port configured to receive the syringe 12 and positioned to emitan electromagnetic radiation beam, for example, in the axial directionthrough the syringe barrel 18. Accordingly, in some examples, theelectromagnetic radiation source 112 can be integrated with the injector10 (shown in FIG. 1). For example, the electromagnetic radiation source112 can be positioned on the injector port 16 (shown in FIG. 1),adjacent to the drip flange 28 of the syringe barrel 18, or at someother convenient location on the injector adjacent to the syringe port.

In other examples, the fluid verification system 110 can be a standalonestructure including a base or holder for receiving a syringe 12 to betested. The electromagnetic radiation source 112, such as the LED orstandard light bulb, can be positioned on or adjacent to the base orholder. In that case, the syringe 12 is verified to ensure that it isproperly filled with fluid F. After verification is completed, syringe12 is removed from the base or holder and transferred to an injector,such as fluid injector 10, for delivery of fluid F to the patient.

Electromagnetic radiation passing through the plunger or plunger cover26 substantially radiates through the syringe barrel 18 to form the halo120 when the syringe is filled with fluid. With specific reference toFIG. 7, when the syringe 12 is filled or partially filled with air, theelectromagnetic radiation beams pass through the syringe barrel 18, butdo not form a distinctive illuminated portion or halo 120 near thedistal end 24 thereof. In contrast, as shown in FIG. 8, when the syringe12 is entirely filled with fluid F, the electromagnetic radiation beamsare refracted by the fluid F and the syringe barrel walls, whichproduces a halo 120 near the distal end 24 of the syringe 12. Asdiscussed in greater detail in connection with the methods and steps forsyringe verification herein, a system operator or automated imagereading or optical device (e.g. sensor 114) can identify whether thehalo 120 is present and, if present, is the correct shape and size. Ifthe halo 120 is too small, not bright enough, or not present at all,this may indicate that the syringe is not filled with sufficient fluidor contains air, and the system operator can add additional fluid F tothe syringe 12 for complete filling prior to injection into a patient.If a halo 120 having the correct size, shape, and brightness isidentified, then verification that the syringe is filled with fluid iscomplete and the fluid contents of the syringe 12 are ready foradministration to a patient. Accordingly, fluid verification system 110provides a suitable visual indication of whether a syringe 12 is full offluid or whether even a small amount of air is present in the syringeinterior 19.

In addition, as shown in FIGS. 7 and 8, a line 40 may be formed on adistal end 24 of the syringe barrel 18 and extend around a circumferenceof the distal end 24 of the syringe barrel 18. The line 40 may be formedon the barrel 18 using any suitable method such as, but not limited to,printing, overmolding, and etching. The line 40 is configured to work inconjunction with the halo 120 to provide the operator with a quick,visual indication of the type of fluid within the syringe 12. Forexample, the halo 120 will be different sizes depending on the type offluid present within the syringe due to different properties ofdifferent fluids. Accordingly, the line 40 may be formed on the syringe12 to align with a particular portion of the halo 120, such as thebottom edge as shown in FIG. 8, when a first fluid is present within thesyringe 12 and to align with a second predetermined portion of the halo120, such as a middle portion, if a second fluid is present within thesyringe 12 or may be positioned away from the halo 120 if the secondfluid is present within the syringe 12. In this manner, the operator canquickly and easily visually determine the location of the line 40 inrelation to the halo 120 and, based on this information, determine thetype of fluid present within the syringe 12.

With reference to FIG. 9, another example of a syringe 12 and fluidverification system 110, including a backlight translucent ortransparent plunger or plunger cover 26, is illustrated. The syringe 12is mounted to a syringe port 16 of an injector 10. One or moreelectromagnetic radiation sources 112, such as LEDs, are mounted to orembedded in a distal end of a piston rod 124 of the injector 10. Whenactuated, the piston rod 124 advances toward and is received within thecavity 27 defined by the plunger or plunger cover 26. The LEDs emitlight in the axial direction through the plunger cover 26 for producingthe halo 120 adjacent to the distal end 24 of the syringe barrel 18 inthe manner discussed above. The halo 120 can be identified by the sensor114 positioned adjacent to the distal end 24 of the syringe barrel 18.

2. Electromagnetic Radiation Source Positioned so that RadiationReflects from the Surface of the Plunger

With reference to FIG. 10, the radiation source 112 can also be arrangedor positioned so that energy or electromagnetic radiation reflects froma distal surface 26A of the plunger or plunger cover 26 axially throughthe syringe barrel 18 to form the halo 120. For example, anelectromagnetic radiation source 112, such as described herein, could bepositioned outside the barrel, for example, near the distal end 24 ofthe barrel 18 to project an electromagnetic radiation or light beam Btoward the distal surface 26A of the plunger or plunger cover 26 throughthe syringe barrel 18. The electromagnetic radiation or light beam Bthen reflects off the plunger or plunger cover 26 in the distaldirection with concomitant refraction/reflection by the fluid and/orsyringe wall material to form a visible halo at the distal end of thesyringe.

3. Electromagnetic Radiation Source Positioned Adjacent to the Surfaceof the Injector

In another example, as shown in FIG. 11, the system 110 can include anelectromagnetic radiation source 112 positioned adjacent to the surfaceof the injector 10 and/or syringe port 16 (shown in FIG. 1). Theelectromagnetic radiation source 112, such as described herein, can beconfigured to focus and reflect a light or radiation beam B from amirror 122 or other reflective element located near the distal end 24 ofthe syringe barrel 18. The mirror 122 directs the light orelectromagnetic radiation beam toward the distal surface 26A of theplunger or plunger cover 26, so that the radiation or light can reflectfrom the plunger or plunger cover 26 to form the halo 120 when thesyringe is filled with fluid. The halo 120 can be identified visually bythe operator or by the detector or sensor 114.

4. Electromagnetic Radiation Source Including Fiber Optics

With reference to FIG. 12, in another example, a fiber optic light pipe126 is used to provide light or electromagnetic radiation from anelectromagnetic radiation source 112 toward the distal end 24 of thebarrel 18, for example wherein the source is associated with theinjector body, and to shine or direct the light toward the distalsurface 26A of the plunger or plunger cover 26. In one example, thelight pipe 126 can be embedded in the syringe barrel 18 itself.Alternatively, the light pipe 126 may be embedded in a pressure jacketsurrounding the syringe barrel 18. In that case, light can be directedfrom the electromagnetic radiation source 112 located, for example, inthe syringe port 16 of the injector 10 through the light pipe 126 towardthe distal end 24 of the barrel 18. Light emitted from the light pipe126 is shown or directed toward the distal surface 26A of the plunger orplunger cover 26 as shown by the light beam B, and permitted to reflecttherefrom in the manner discussed in connection with the examplesillustrated in FIGS. 10 and 11 to form a halo at the distal end of thesyringe when the syringe is filled with fluid.

5. The Illuminated Identification Pattern or Halo

With reference to FIG. 13, details of how electromagnetic radiation isrefracted by fluid F and/or the material in the wall of barrel 18 toproduce the halo 120 will be discussed in detail. As shown in FIG. 13,light rays, denoted generally as 130, which are scattered in multipleorientations when passing through the plunger or plunger cover 26 (shownin FIGS. 6 and 9), travel generally in the axial direction A toward thedistal end 24 of the syringe barrel 18. Some of the light rays 130 exitthe syringe barrel 18 through the transparent or translucent sidewall ofthe syringe barrel 18, meaning that the illuminated plunger 26 isvisible to an observer 200. Some light rays 130 reach the tapered,conical distal end 24 of the barrel 18 directly without contacting thesidewall of the barrel 18. Light rays 130 shining directly on the distalend 24 of the barrel 18 would be visible to an observer 200 looking at atop of the syringe 12 from an elevated position. Some light rays 130 arefocused to the distal end 24 of the syringe barrel 18 by total orpartial internal reflectance, shown at reference number 132, from thesyringe barrel 18. For example, light rays 130 directed to one side ofthe tapered, conical distal end 24 of the syringe barrel 18 arereflected by total internal reflectance, as shown at number 133, towardthe opposite side of the tapered distal end 24 when the syringe isfilled with fluid and the difference in refractive index between thefluid, the syringe wall material and the air outside the syringe aredifferent to cause internal reflection. If the syringe barrel 18 isfilled completely with air or only partially filled with fluid F, thelight rays 130 are not sufficiently internally reflected or focused tothe distal conical end and would be only faintly visible, if at all, toan observer 200 over the area of syringe 12 filled with air. Withoutintending to be limited by any theory, it is believed that a largepercentage of the light rays travelling through the volume of thesyringe containing air are not internally reflected at the syringebarrel wall and, instead, exit the syringe through the sidewall; andsince there is no substantial internal reflection, the light rays arenot focused to the distal end of the syringe to produce an observablehalo. In particular, focused light rays 130 would not be visible as ahalo when looking at the syringe barrel 18 from a straight-on positionor true side view when air is in the syringe. Thus, the halo 120 doesnot appear to be present when the syringe barrel 18 is not fully filledwith fluid.

However, as shown in FIG. 13, when the syringe 12 is filled with fluidF, the light rays 130 reflected toward and focused to the tapered distalend 24 of the barrel 18 are refracted, as shown at line 131, due to thedifference in refractive index of the fluid relative to the outside airand the syringe wall material. Specifically, as discussed herein, airhas a refractive index of substantially 1. In comparison, the refractiveindex of saline is about 1.34, the refractive index of contrast is about1.46, and the refractive index of PET is about 1.57. The refracted lightbeams 130 exiting the syringe barrel 18 are viewable to an observer 200at a lower angle compared to when the syringe barrel 18 is onlypartially filled with the fluid F. Further, due to the refraction, thelight rays 130 may be further focused to increase the intensity of thelight halo observed by the observer 200. Accordingly, when looking atthe fluid filled syringe 12 at a straight-on, true side view, orslightly elevated position, the observer 200 sees the illuminated halo120 which has a distinctive appearance.

The structure and geometries of the syringe 12 and particularly thetapered, conical distal end are chosen to ensure that the halo 120 iseasily visible at a predetermined portion of the barrel 18 (i.e., thedistal end 24) from a particular set of positions or orientations. Forexample, in some embodiments, the injector 10 holds the syringe 12 at atilted orientation (e.g., either leaning upwards or downwards frombetween about 0 to about 30 degrees relative to plane of the injector).To account for the tilted orientation of the syringe 12, the shape ofthe barrel 18 and distal end 24 of the barrel 18 can be selected toincrease visibility of the halo 120 when viewed in a tilted position. Ifthe syringe 12 is held in a substantially straight (e.g., not tilted)position by the injector 10, then the syringe 12 is shaped so that thehalo 120 can be easily seen when the syringe 12 is viewed from astraight-on or true side view orientation.

More specifically, with reference to FIG. 14A, if the syringe 12 isoriented such that it is generally viewed from a straight-on or tiltedback (e.g., from 10 degrees to 30 degrees tilt) orientation, the angle23 of the tapered distal end 24 of the barrel 18 is from about 30degrees to 60 degrees, and in certain embodiments about 45 degreesrelative to the horizontal. An angle of about 45 degrees creates a halo120 that may be more easily seen than at a straight-on view angle. Inparticular, as shown in FIG. 14A, the observer 200 can see the lightrays 130 that form the halo 120 at a rather low orientation.

In contrast, as shown in FIG. 14B, for a syringe 12 having a distal end24 with a steeper angle 23, the halo 120 is visible to the observer 200at a higher (e.g., downward looking) orientation. If the syringe 12 isexpected to be viewed in a tilted forward position, the higher viewpointmay be appropriate. In some examples, the distal end 24 of the barrel 18can also have a dome shape. However, in most circumstances, the halo 120may be easier to see through a tapered distal end 24 rather than a domeshaped distal end 24.

In another example, as shown in FIG. 14C, the distal end of the syringe12 includes a distal portion 24 that includes a curved and angledportion extending from the barrel 18 to the nozzle 22 or tip. The distalportion 24 having such a curved and angled portion produces a halo 120that can be seen from a wider range of viewing angles. In particular, asshown in FIG. 14C, the light beams 130 can be seen by the observer 200at either the straight-on orientation or a more downwardly directedorientation. Accordingly, for a syringe 12 having a distal portion 24 asshown in FIG. 14C, the halo 120 is visible regardless of whether theinjector 10 holds the syringe 12 in a slightly tilted or straightposition.

6. Operation of Fluid Injection System with the Exemplary Syringe

With reference again to FIGS. 1, 2, and 6, in use, an operator insertsthe proximal end 20 of the barrel 18 into a corresponding syringe port16. The operator may be required to exert some force against eachsyringe 12 so that the locking flange 32 of the syringe 12 engages withcorresponding locking structures (not shown) of the syringe port 16 toform a suitable connection therewith. In certain examples, the operatorcontinues to press the syringe 12 into the port 16 until the insertionportion 30 of the syringe barrel 18 is entirely inserted. In some casesan audible or tactile signal, such as a click, indicates that thesyringe barrel is fully inserted, locked, and ready for use.

The syringe 12 may be preloaded with a fluid F. Alternatively, theinjector 10 can automatically or manually draw fluid F into the syringebarrel 18 from an external fluid source. Once the syringe 12 is insertedin the port 16 and filled with fluid F, the electromagnetic radiationsource 112 is turned on causing light beams to project through theplunger or plunger cover 26. Alternatively, as discussed herein inconnection with the exemplary systems illustrated in FIGS. 10-12,electromagnetic radiation or light can be directed toward the distalsurface 26A of the plunger cover 26 and reflected therefrom in the axialdirection. In some examples, syringe insertion and halo identificationcan be coordinated such that the electromagnetic radiation source 112turns on automatically each time that a syringe 12 is loaded into theinjector 10. Alternatively, the system operator can manually turn on theelectromagnetic radiation source 112 by, for example, inputting acommand through the user interface or pressing an activation button.Once the electromagnetic radiation source 112 is activated, the presenceor absence of the illuminated portion or halo 120 (shown in FIGS. 6 and9) can be identified and/or detected, either by the technician orautomatically by the sensor. Specifically, if the syringe 12 is fullyfilled with the fluid F, the halo 120 appears. If the syringe 12 isfilled with air or only partially filled with fluid, then the halo 120is either less pronounced or entirely absent. For example, the halo 120begins to become less pronounced (i.e., smaller in size and/or lessbright) as soon as air is introduced into the syringe and continues tofade until it is entirely absent when about 5 mL of air is present in asyringe 12 of the distal end of the syringe when a syringe such as thesyringe shown in FIG. 2 is utilized in the system. In other examples,the halo 120 is not visible when a percentage of a volume of air presentin the distal end 24 of the syringe 12 is greater than about 15% of thevolume of the conical shaped distal end 24 of the syringe 12. In stillother examples, the halo 120 is not visible when a percentage of avolume of air present in the distal end 24 of the syringe 12 is greaterthan about 10% of the volume of the conical shaped distal end 24 of thesyringe 12, and in yet other examples, the halo 120 is not visible whena percentage of a volume of air present in the distal end 24 of thesyringe 12 is greater than about 20% of the volume of the conical shapeddistal end 24 of the syringe 12. In some examples, the system operatormanually confirms, such as by visual verification, that the halo 120 ispresent before actuating the injector 10.

Alternatively, according to another aspect of the present disclosure,the illuminated halo 120 can be detected automatically by one or moresensors 114, such as a digital camera. More specifically, an image orimages of the distal end 24 of the barrel 18 may be obtained by the oneor more sensors 114. The obtained image can be analyzed by a processorusing image processing techniques (as will be discussed in greaterdetail herein). For example and as will be discussed in detail herein,pattern recognition algorithms can be used to identify an expectedstructure and other properties of the syringe 12, fluid fill volume,fluid properties, and shape and/or location of the halo 120, among otherproperties and features. The pattern recognition can also be used toidentify information about the syringe 12, such as syringe fluid volumeor preferred injection parameters for a particular syringe size andgeometry. Edge to edge distance calculating algorithms can be used toidentify the position and length of the halo 120. Edge to edge distancecalculating algorithms can also be used to determine a length of themeniscus formed by the fluid F contained in the syringe 12. Recognitionof the meniscus position and size can be used to determine the fluidvolume contained in the syringe 12 and free space (i.e. air volume), ifany, between the meniscus and syringe nozzle. Brightness determiningalgorithms can be used to determine the intensity of the halo 120. Aspreviously discussed, the brightness of the halo 120 may be used as anindicator of an amount of air present in the syringe 12. Accordingly,the processing algorithm could ensure that the halo brightness exceedscertain predetermined threshold values thus indicating that thresholdamounts of air in the syringe are not exceeded.

In some examples, the injector 10 can be configured to “unlock/lock”based on whether the halo 120 is identified. For example, if the halo120 is not identified, the injector 10 could enter a “locked” statepreventing an injection from proceeding and/or request that the testedsyringe be replaced with a new one. If the halo 120 is identified, theinjector 10 may “unlock” and allow the operator to access other featuresof the user interface of the injector 10 and allow the injectionprocedure to proceed. Similarly, the injector 10 can be configured tocancel or halt a scheduled injection procedure if the sensor 114 failsto identify the halo 120 or if the halo 120 is identified but is not ofsufficient brightness. If the halo 120 is present, the injector 10 canbe configured to automatically begin the injection procedure. Activatingthe injector 10 causes the linear actuator to advance the piston rod 124in the distal direction to contact and engage the plunger or plungercover 26. Advancing the plunger or plunger cover 26 in the distaldirection through the barrel 18 expels fluid F from the syringe 12,thereby injecting fluid F into the patient through any known injectionstructure, such as an IV tube or needle accessory.

D. Alternative Exemplary Syringe for Use with Fluid Injection System

1. Structure of Alternative Exemplary Syringe

FIGS. 15A and 15B illustrate an alternative exemplary syringe that maybe utilized with fluid injector 10. More specifically, these figuresillustrate a rolling diaphragm syringe 135 in accordance with anotheraspect of the present disclosure. Various features of a rollingdiaphragm syringe are described in detail in International PCTApplication Publication No. WO 2015/164783, the disclosure of which isincorporated by this reference. FIG. 15B is a cross-sectional side viewthe rolling diaphragm syringe 135 shown in FIG. 15A taken along lineA-A. Referring initially to FIG. 15A, the rolling diaphragm syringe 135generally includes a hollow body that includes a forward or distal end137, a rearward or proximal end 139, and a flexible sidewall 134extending therebetween. The sidewall 134 of the rolling diaphragmsyringe 135 defines a soft, pliable or flexible, yet self-supportingbody that is configured to roll upon itself, as a “rolling diaphragm”,under the action of a piston 138 (shown in FIGS. 18A and 18B) of thefluid injection 10. In particular, the sidewall 134 of the rollingdiaphragm syringe 135 is configured to roll such that its outer surfaceis folded and inverted in a radially inward direction as the piston 138is moved in a distal direction and unroll and unfold in the oppositemanner in a radially outward direction as the piston 138, for example apiston releasably attached to a proximal end of an end wall 136 of therolling diaphragm syringe 135, is retracted in a proximal direction.

The rolling diaphragm syringe 135 may be made of any suitablemedical-grade plastic or polymeric material. In various aspects, theclear plastic material may withstand sterilization procedures, such asexposure to ethylene oxide or electromagnetic radiation sterilizationprocedures.

With reference to FIG. 15B and with continued reference to FIG. 15A, thedistal end 137 of the rolling diaphragm syringe 135 has an open-endeddischarge neck 140 having a connection member 140 a for connecting to acorresponding connection member, for example the cap of FIG. 17 asdescribed herein, which may connect to a fluid path set (not shown). Thedischarge neck 140 has a first sidewall thickness T₁ that is greaterthan a thickness T₂ of a sidewall 134. Thickness T₁ is selected suchthat the discharge neck 140 may be sufficiently rigid to allow forconnecting to a corresponding connection member of a fluid path set (notshown) without substantially deforming the discharge neck 140, forexample during an injection procedure. Thickness T₂ is selected suchthat the sidewall 134 of the rolling diaphragm syringe 135 is flexibleto allow for rolling over and unrolling of the sidewall 134 as describedherein. The proximal end 139 of the rolling diaphragm syringe 135, suchas closed end wall 136, may be reinforced to prevent deformation duringrolling over, or in particular aspects, unrolling of the sidewall 134.In some aspects, the proximal end 139 of the rolling diaphragm syringe135 is configured for engagement with the piston 138.

The end wall 136 may have a central portion 276 having a substantiallydome-shaped structure and a piston engagement portion 244 extendingproximally from the central portion 276, such as an approximate midpointof the central portion 276. In some aspects, a distal most end of thecentral portion 276 may be substantially flat. The piston engagementportion 244 is configured for engagement with the engagement mechanismon the piston 138 of the fluid injector 10. The proximal end 139 of therolling diaphragm syringe 135 may have one or more ribs 278 protrudingradially outward from the piston engagement portion 244 along a proximalsurface of a ramp 272.

FIG. 16A is a perspective view of a syringe assembly 204 having arolling diaphragm syringe 135 (shown in FIG. 16B) and a pressure jacket210 in accordance with the present disclosure. The syringe assembly 204includes the pressure jacket 210 that removably interfaces with theinjector 10 (shown in FIG. 1), as described herein. The pressure jacket210 has a distal end 216, a proximal end 218, and a sidewall 219extending between the distal end 216 and the proximal end 218 along alongitudinal axis of the pressure jacket 210 to define an internalthroughbore 221 (shown in FIG. 16B). In some aspects, the sidewall 219of the pressure jacket 210 is shaped to receive at least a portion ofthe rolling diaphragm syringe 135 (shown in FIG. 16B) within thethroughbore 221. The sidewall 219 of the pressure jacket 210 has a firstdistal portion 360 a for receiving at least a portion of the rollingdiaphragm syringe 135, and a second proximal portion 360 b forinterfacing with the injector 10. The first distal portion 360 a mayhave an open end configured to releasably receive a cap 390 thatencloses the interior of the pressure jacket 210. The second proximalportion 360 b may have an open end to allow the piston 138 of the fluidinjector 10 to extend through the open end and engage rolling diaphragmsyringe 135 held within throughbore 221. The rolling diaphragm syringe135 may be inserted through the open end of the first distal portion 360a or the second proximal portion 360 b.

In some aspects, the second proximal portion 360 b has a locking lug orlip 370 protruding radially outward from an outer surface of the secondproximal portion 360 b. The locking lug or lip 370 may extendcontinuously or discontinuously around an outer circumference of thesecond proximal portion 360 b. The locking lug or lip 370 is configuredfor interacting with corresponding features on the fluid injector 10 toreleasably lock the pressure jacket 210 with the fluid injector 10. Insome aspects, the locking lug or lip 370 may have a connection member toreleasably secure the pressure jacket 210 to a corresponding lockingmechanism of the fluid injector 10 described in U.S. Pat. Nos.5,383,858; 5,873,861; 6,652,489; 9,173,995; and 9,199,033. Otherconnection members between the pressure jacket 210 and the fluidinjector 10 are described in International Application No.PCT/US2015/057751, filed Oct. 28, 2015, or International Application No.PCT/US2015/057747, filed Oct. 28, 2015, which are hereby incorporated byreference.

With reference to FIG. 16B and with continued reference to FIG. 16A, thepressure jacket 210 may have a cap 390 that is releasably secured to thedistal end 216. In some aspects, the cap 390 may be secured by athreaded engagement, a bayonet fitting, or another mechanical fasteningarrangement with the distal end 216 of the pressure jacket 210. Forexample, as shown in FIGS. 16B and 16C, the cap 390 may have at leastone projection 430 that is received inside at least one groove 440 onthe pressure jacket 210 such that the cap 390 may be locked with thepressure jacket 210 by aligning the at least one projection 430 to fitwithin the groove 440. The cap 390 may have an inner element 400 with anozzle 410. The nozzle 410 may be in fluid communication with theinterior volume of the rolling diaphragm syringe 135 (or directly formedon the rolling diaphragm syringe 135) to deliver fluid into or from therolling diaphragm syringe 135. The nozzle 410 may have a connectionmember 420 for removably connecting to a connector of fluid path set 17(shown in FIG. 1).

The annular sidewall 460 may have one or more gripping elements 470(shown in FIG. 16C) to facilitate gripping of the cap 390 when the cap390 is connected to and/or disconnected from the pressure jacket 210.The cap 390 may have a radial flange 480 that extends radially outwardfrom a proximal portion of the annular sidewall 460.

With reference to FIG. 16C, at least a portion of the rolling diaphragmsyringe 135 may be removably secured to the cap 390. In some aspects,the cap 390 may have a connection member that corresponds to andconnects with the connection member 140 a (shown in FIG. 15A) of therolling diaphragm syringe 135. As further shown in FIG. 16C, the rollingdiaphragm syringe 135 may initially be in a compressed configurationwhere the rolling diaphragm syringe 135 is rolled over on itself.Providing the rolling diaphragm syringe 135 in an initial compressedconfiguration may provide economic benefits during packaging andshipping by requiring less packaging material per syringe set up and/orallowing more syringe set-ups to be packaged.

2. Generating an Illuminated Identification Pattern with the AlternativeExemplary Syringe

Having generally described the structure of the rolling diaphragmsyringe 135, systems for generating an illuminated identificationpattern with the rolling diaphragm syringe 135 to determine a fillstatus of the rolling diaphragm syringe 135 will be discussed in detail.In one example, with reference to FIGS. 17A and 17B, the piston 138 ofthe fluid injector 10 may have one or more electromagnetic radiationsources 212, such as LEDs, mounted to or embedded in a distal endthereof. When actuated, the piston 138 advances toward and engages thepiston engagement portion 244 of the rolling diaphragm syringe 135. TheLEDs emit light in the axial direction through the piston engagementportion 244 for producing an illuminated identification pattern at adistal end 137 of the rolling diaphragm syringe 135.

The wavelength of the electromagnetic radiation of the LEDs is chosen tomatch the material used to form the rolling diaphragm syringe to allowfor the best transfer of energy. For example, the windows of a car arecreated from a material that prevents UV light from passing through toprevent sunburns while driving. The same principle holds true in thepresent application. The wavelength of the LEDs may be chosen to matchthe material used to manufacture the syringe to ensure maximumtransmittance through the material of the piston engagement portion 244and/or the wall thickness of syringe. Alternatively, instead of choosingthe wavelength to match the material, a wavelength for the LEDs may bechosen that is the most visible to the human eye when combined with thehalo effect described herein. For example, green light lies in themiddle of the visible spectrum (approximately 532 nm) allowing lighthaving such a wavelength to be readily visible to a technician. Also,depending on the solute concentration of the fluid contained within thesyringe, along with the compounds present and their chemical properties,wavelengths for the LEDs can be selected to be selectively absorbed ortransmitted by the fluid or having the desired reflection/dispersionproperties. Accordingly, a wavelength of LEDs may be selected such thatthe light produced by the LEDs is dispersed by the fluid and generatesmore light therein, or the light may be absorbed/transmitted by thefluid and passes through similar to how the halo 120 is formed asdescribed herein.

In other examples, the electromagnetic radiation source may bepositioned in a variety of other locations such as, but not limited to,the piston engagement portion 244 of the rolling diaphragm syringe 135,the pressure jacket 210, external of the fluid injector 10 similar tothe arrangement shown in FIGS. 10 and 11, a heat maintainer associatedwith the pressure jacket 210, or any other suitable location. In oneexample, with reference to FIGS. 18A and 18B, the electromagneticradiation sources 212 may be positioned within another portion of thefluid injector, such as a clamp 213 positioned at the distal end of thesyringe 135 used to secure the syringe 135 within the fluid injector.For instance, with reference to FIG. 18A, the electromagnetic radiationsources 212 may be positioned around a circumference of the side of theclamp 213 to direct light through the sides of the pressure jacket 210to the syringe 135. Alternatively, with reference to FIG. 18B, theelectromagnetic radiation sources 212 may be positioned on a top surfaceof the clamp 213 to direct light down through the syringe 135.

In one example, an end of the piston engagement portion 244 may beconfigured to expose the LEDs of the piston 138 when the piston 138engages the piston engagement portion 244. More particularly, the pistonengagement portion 244 may be configured to disengage a cover (notshown) to expose the LEDs when the piston 138 engages the pistonengagement portion 244.

The piston engagement portion 244 of the rolling diaphragm syringe 135may be shaped in a manner to collect light from the LEDs and directlight through the interior volume 214 of the rolling diaphragm syringe135 towards the distal end thereof. For instance, the piston engagementportion 244 may have a convex lens shaped portion such that the portionfocuses the light produced by the electromagnetic radiation sources 212and directs the light up the piston engagement portion 244. In addition,if the light sources of the electromagnetic radiation sources arecollimated, then the shape of certain portions of the piston engagementportion 244 may be flat or any other suitable geometrical shape.

The piston engagement portion 244 may also have a textured surface toenhance the light collecting and transmission capabilities thereof. Inaddition, the central portion 276 of the end wall 136 may also include atextured surface to enhance the transmission of light to the distal end137 of the rolling diaphragm syringe 135 when the rolling diaphragmsyringe 135 is filled with fluid, and diffuse light when the rollingdiaphragm syringe 135 is filled with air or partially filled with air.Alternatively, central portion 276 of end wall 136 may be a lens toenhance transmission of light to the distal end 137 of the rollingdiaphragm syringe 135.

In another example, as shown in FIGS. 19A and 19B, the pressure jacket210 may include the electromagnetic radiation source 212 as mentionedherein positioned at the proximal end 218 thereof. In such instances,the light produced by the electromagnetic radiation sources 212 may bedirected up through the pressure jacket 210, and internal reflectionwithin the pressure jacket 210 creates the illuminated identificationpattern at the conical distal end 137 of the rolling diaphragm syringe135 when the syringe is filled with fluid. In another aspect, thepressure jacket 210 may be coated with a substance that produces a “oneway mirror” to properly distribute the internal reflection of theelectromagnetic radiation while allowing observation by the technician.In addition or alternatively, the electromagnetic radiation source andthe pressure jacket 210 may be polarized to prevent electromagneticradiation from exiting pressure jacket 210.

The electromagnetic radiation is collected and directed towards thedistal end 137 of the rolling diaphragm syringe 135 to create anilluminated identification pattern when filled with fluid. The inside ofthe distal end 137 of the rolling diaphragm syringe 135 may be angledsimilar to distal end 24 of syringe 12 discussed herein to generate ahalo 120 in a similar manner. Alternatively or in addition, as shown inFIG. 20, a protruding component 224 may be incorporated in or positionednear the distal end 137 of the rolling diaphragm syringe 135 todistribute the light to generate the halo 120. The protruding component224 may have various configurations for various purposes. For example,the protruding component 224 may be a reflective surface that reflectslight in various directions to enhance visualization of the halo 120 orto show another indication that fluid is present. The protrudingcomponent 224 may be a prism, mirror, textured surface, or some othergeometrical/material alteration to disperse/absorb light in such a waythat it allows for indication of fluid presence, fluid type, or othercharacteristics of the syringe 135.

Since a cap 390 may be used with rolling diaphragm syringe 135 asdescribed herein, the cap 390 may be manufactured from a translucent ortransparent material so that the halo may be observed through the capmaterial. As the electromagnetic radiation is transmitted to the distalend 137 of the rolling diaphragm syringe 135, it causes such atransparent or translucent cap 390 to illuminate. The intensity of theillumination of the cap 390 varies depending on the fluid containedwithin the syringe as described herein. For instance, if a fluid isprovided within the syringe, the cap 390 is illuminated much brighterthan if air is present within the syringe.

II. Image Recognition of the Illuminated Identification Pattern andVarious Other Aspects of the Fluid Injection System

Having discussed various examples of radiation sources, syringes, howthe electromagnetic radiation or light beam is directed through thesyringe to form an illuminated identification pattern, sensors 114 foridentifying the illuminated identification pattern and for monitoring orcontrolling operation of the injector 10 (shown in FIG. 1) based onidentification of the illuminated identification pattern and variousother aspects of the fluid injector 10 will now be discussed in detail.While the systems and methods discussed herein with be discussed withreference to the fluid injector 10 including the syringe 12, all of theconcepts discussed herein may be utilized with the rolling diaphragmsyringe 135 as well.

With reference to FIGS. 1, 6, and 9-12, the fluid verification system110 is configured as an image recognition system that includes at leastone sensor 114, such as an image capture device, positioned having afield of view directed to at least the distal end 24 of the syringe 12,a central processing unit 116 including a controller operativelyconnected to the sensor 114 and configured to process the imagesobtained from the sensor 114 using suitable image processing software,and a display 118 operatively connected to the central processing unit116 for displaying the results of the image processing performed by thecentral processing unit. In one example, the image processing softwaremay be the Insight Explorer software from Cognex Corporation of Natick,Mass. and the sensor 114 may be a DataMan 100 camera also from CognexCorporation. In addition, the at least one sensor 114 and the centralprocessing unit 116 may be integrated into a single component orprovided as individual components. Further, the at least one sensor 114,the fluid injector 10, the display 118, and/or the central processingunit 116 may be in wired communication or may communicate wirelessly,for example via Bluetooth, WiFi, or other conventional wirelesscommunication technology.

In another example, the sensors 114 can be an alternative type ofoptical sensor, such as an electromagnetic radiation detector or othersuitable sensor as is known in the art. In some examples, the at leastone sensor 114 is a digital camera that can be configured to obtain adigital image of at least the distal end 24 of the barrel 18 when theelectromagnetic radiation source 112 is turned on. In other examples,the at least one sensor 114 can be an infrared radiation detector,ultraviolet light detector, ultrasound imaging device, or any othersuitable sensor for identifying electromagnetic radiation emitted fromthe electromagnetic radiation source 112.

As will be appreciated by one of ordinary skill in the art, the at leastone sensor 114 or detector can be adapted specifically for identifying awavelength of electromagnetic radiation or light associated with theelectromagnetic radiation source 112 and the illuminated identificationpattern produced therewith. For example, the at least one sensor 114 caninclude various filters or tuned or attenuated optical elements foridentifying only radiation within an expected wavelength (e.g.,electromagnetic radiation within a wavelength emitted by theelectromagnetic radiation source 112). Additionally, the syringe 12itself can be used as a filter by altering the material properties(e.g., color, molecular alignment, pigment additive, polarized surface)to filter light of a given wavelength to achieve an optimizedvisualization by the user. Alternatively, image processing techniques,known in the art, can be used to remove portions of obtained imagesoutside of the expected wavelength, thereby reducing an influence ofambient light and increasing sensitivity for the illuminatedidentification pattern.

Using features of the fluid verification system 110 described herein,various aspects of a fluid injection procedure can be monitored prior toand during delivery of a fluid to quickly provide information to atechnician of details of the injection procedure in a readily apparentmanner. These details of the injection will be discussed herein.

A. Air Detection

1. Using an Image of an Illuminated Identification Pattern

All current injector systems rely upon the personal inspection of thetechnician to determine if air is present in the syringe prior to thestart of an injection procedure. The fluid verification system 110 isconfigured to provide detection of air using at least one sensor 114 andimage recognition software executed by a central processing unit 116 toallow the technician to have additional corroboration of his/herconclusion on the status of the syringes. In addition, the techniciancan manually determine whether air is present by looking at the syringeto determine whether the illuminated identification pattern is presentthus providing an alternative or two-pronged approach to air detection.

In one example, the fluid verification system 110 determines whether airis present by taking an image of the distal end of the syringe 12 todetermine if the halo 120 has been generated in the syringe 12 by theelectromagnetic radiation source 212 with the sensor 114 and using theimage recognition software of the central processing unit 116 to reviewand analyze the image to measure one or more properties of the halo 120or illuminated identification pattern to determine if the syringe isproperly filled with fluid prior to injection. More specificallyaccording to one aspect and with reference to FIG. 21, at step 300, theat least one sensor 114 is positioned to capture an image of at least aportion of the syringe 12 that includes the halo 120 or otherilluminated identification pattern. Thereafter, and with reference toFIGS. 22 and 23, at step 302, a bottom edge 301 of a meniscus of thefluid contained within the syringe 12 and/or the bottom edge 303 of thehalo 120 is measured or determined by the system 110. These edges 301,303 are identified in the image by the software provided on the centralprocessing unit 116. More specifically, the image processing softwareexecuted by the central processing unit 116 may be able to detect theedges through a variety of different methods. One method is to determinethe change in contrast between neighboring pixels in the image of theedge. Alternatively, a contrast change over several adjacent pixelsmight indicate the presence of the edge. This change is indexed overeach pixel within a search window to find areas where the contrastchange reaches a threshold. For example, the change is flagged if theimage recognition software finds a spot where a light colored pixel isadjacent to a dark pixel. If it is found that this threshold is crossedwith several pixels in a row, oriented specifically in a predetermineddirection, then the image processing software determines that this is an“edge”. In this particular application, the dispersion of light causedby the lens effect of the meniscus causes a darkened area of fluid atthe meniscus location. Specifically, there is an edge that can be foundat the top and the bottom of the meniscus as shown most clearly in FIG.23.

FIG. 22 is an image of a syringe 12 where no air is present, and FIG. 23is an image obtained by sensor 114 where air is present in the syringe12. As can be seen from these images, the halo 120 is larger when no airis present as shown in FIG. 22. This allows for the determination of airusing imaging processing techniques as discussed in detail herein.

At step 304, a distance 305 from the bottom edge 301 of the meniscus tothe bottom edge 303 of the halo 120 is determined using the imageprocessing software provided on the central processing unit 116. Oncethe bottom edge 301 of the meniscus is determined, the location of thisedge in space can be found. Specifically, the bottom edge 303 of thehalo 120 can be determined and this bottom edge 303 of the halo 120always stays fixed as long as the syringe 12 and the sensor 114 do notmove. Accordingly, the image processing software is then able todetermine a distance from the bottom edge 301 of the meniscus to thebottom edge 303 of halo 120.

At step 306, the distance 305 determined in step 304 is compared to apredetermined distance. The predetermined distance was found by creatinga curve, such as the curve shown in FIG. 24. This curve was created bytaking a full syringe 12 and replacing known increments of fluid withequal volumes of air. Images were then taken after each increment offluid was replaced and the distance from the bottom edge of the meniscusto the bottom edge of the halo 120 was measured using the imagerecognition software on the central processing unit 116. The curve isthen plotted and an equation is fit. The equation is then provided to alogic algorithm in which the data of the curve in FIG. 24 is embodied tocalculate the volume of air present based on the distance between thetwo edges.

If the measured distance 305 is greater than the predetermined distance,it can be determined that substantially no air is present and theinjector can be armed to proceed with an injection at step 308. On theother hand, if the measured distance 305 is less than the predetermineddistance, an indication that air is present in the syringe 12 isprovided at step 310 and the fluid injector 10 is disabled fromconducting an injection procedure at step 312. Alternatively, if air ispresent, the fluid injector 10 may perform a purge process to purge theair from the syringe and then repeat the measurement procedure of FIG.21. This purge process may be repeated until the measuring processindicates that substantially no air is present in the syringe and theinjection procedure may proceed.

2. Using Details Provided on the Barrel of the Syringe

An alternative approach to detecting air in a syringe using imageprocessing techniques is to obtain an image of certain features providedon the barrel of the syringe. Specifically, and with reference to FIGS.25 and 26, the syringe 12 may include at least one fluid dot 339 on thesurface of the syringe 12 that is visible by the sensor through thefluid contained within the syringe 12. The use of fluid dots isdescribed in U.S. Pat. No. 5,254,101, to Trombley, III, the disclosureof which is incorporated in its entirety by this reference. Due to thedifferent properties of different fluids, this dot 339 will have adifferent appearance based on the fluid contained within the syringe.Accordingly, if air is contained within the syringe 12, the fluid dot339 will have a certain configuration, such as an oval shape, whenviewed in an image, which can be detected as followed. First, at step340, the at least one sensor 114 is positioned to capture an image of atleast a portion of the syringe 12 that includes the fluid dot 339through the fluid contained within the syringe 12. Thereafter and withreference to FIG. 27, at step 342, the fluid dot 339 is identified inthe image using pixel contrast thresholds. Specifically, the fluid dot339 is identified by detecting the edges thereof in a manner similar tothe manner in which the bottom edge of the meniscus is determined asdescribed herein.

Next, at step 344, since the shape of the fluid dot 339 when variousfluids are provided within the syringe are known, pattern matchingtechniques can be utilized to determine whether air or fluid is withinthe syringe 12. Accordingly, a template of a fluid dot 339 when fluid ispresent within the syringe can be matched to the image obtained in step340. At step 346, if the template matches the image obtained in step340, it can be determined that no air is present and the injector can bearmed to proceed with an injection at step 348. On the other hand, ifthe template does not match, an indication that air may be present inthe syringe 12 is provided at step 350 and the fluid injector 10 isdisabled from conducting an injection procedure at step 352 until arepeated analysis step indicates that the air has been removed, forexample by purging.

While fluid dots 339 were described herein as being utilized, variousother shapes can be utilized and imaged to determine whether air ispresent in the syringe. This is due to the fact that a cylindricalsyringe barrel is, in effect, a lens itself. Utilizing the curvature ofthe barrel wall, images can be captured which will appear different tothe at least one sensor 114 if there is air or fluid in the syringe 12.This phenomenon can be utilized to detect the presence of gross airinside of a syringe. Additionally, the relative size of the image mayallow for determination of fluid type within the syringe (e.g., largerimage will be seen through contrast, while a small image will be seenthrough saline, for example, due to differences in index of refractionbetween the fluids). More specifically, since the syringe barrel 18 actsas a cylindrical lens when it is full of fluid, the fluid dots 339stretch on the horizontal axis. Therefore, an oval shaped fluid dot 339is stretched horizontally without impacting the vertical height. This isthe way the oval fluid dot 339 on an empty syringe becomes a circle ormore circular on a filled syringe to the sensor 114. The sensor maymeasure the change in the horizontal width of the fluid dot 339 todetermine various features of the fluid contained within the syringe.Due to this principle a variety of different shapes may be used toachieve the above described effect of the fluid dots 339, for example bymeasuring differences in the non-vertical features of the fluid dots339.

3. Using Brightness Measurements

According to other aspects, air detection is also possible by imaging aportion of syringe having electromagnetic radiation from a sourcethereof passing therethrough and determining the average pixelbrightness value of a region of interest, such as a portion of thedistal end 24 of the syringe, for example the halo region as describedherein. Such an arrangement is illustrated in FIG. 28, for instance,which shows a syringe 12 filled with contrast having electromagneticradiation, in the form of laser light beam 354, having a specificwavelength, passing therethrough. As can be seen in FIG. 28, when thesyringe is filled with contrast, a path of a distinct laser beam 354 canbe seen as it passes through the contrast. Without being limited by anytheory, it is believed that the contrast agent dissolved in the solutionscatters the electromagnetic radiation in the laser beam 354, providingan observable laser beam pathway. No such laser beam is present if thesyringe 12 is filled with air (see FIG. 27). Accordingly, an averagepixel brightness (e.g., 0-255 intensity units) in an image of theportion of the distal end 24 of the syringe 12 when filled with fluid,as shown in FIG. 28, is much higher than when the syringe is filled withair as evidenced by the presence of laser beam 354 due to scatteredlaser light. Accordingly, the presence of air or contrast can bedetermined using brightness by shining a laser electromagnetic radiationthrough a portion of the syringe barrel, obtaining an image of thesyringe through which the electromagnetic radiation is being passed;determining a region of interest, such as near the distal end 24, of thesyringe; determining the average pixel brightness value for the regionof interest by assigning each 8 bit pixel within the region of interesta brightness value from 0-255 intensity units then averaging thesebrightness values; and comparing the average brightness value to a knownbrightness value to determine whether fluid or air is present within thesyringe 12. Scattering of laser light by contrast, compared tonon-scattering by air, may be observed by shining the laser lightthrough any portion of the fluid in the syringe. In the aspect describedherein, the laser light may be shown through the distal end of thesyringe due to a particular location of the at least one sensor relativeto the syringe barrel. One skilled in the art would recognize that otherlocations of the at least one sensor may be used to determine intensityof laser light depending on the location of the path of the laser light.

B. Fluid Differentiation

All of the above described image processing techniques fordistinguishing air from fluid within a syringe may also be utilized toidentify the type of fluid contained within a syringe. For instance,contrast can be accurately differentiated from saline and differenttypes of contrast can be accurately differentiated from each other usingthe above described imaging processing techniques due to the manner inwhich different fluids interact with light. In particular, withreference to FIGS. 29 and 30, scattering of the laser light may differaccording to the fluid within the syringe. For example, laser beam path354 displays a weak intensity passing through saline compared tointensity of a laser beam path 354 passing through contrast in asyringe.

1. Utilizing the Illuminated Identification Pattern

With further reference to FIGS. 29 and 30, the fluid verification system110 according to various aspects herein may determine whether a syringecontains saline or contrast by taking an image of the halo 120 generatedin the syringe 12 by the electromagnetic radiation source 112 with thesensor 114 and using the image recognition software of the centralprocessing unit 116. While other methods for differentiation betweensaline and contrast are described in detail herein, the same techniquemay be used to differentiate between different types or concentrationsof contrast. First, the at least one sensor 114 is positioned to capturean image of at least a portion of the syringe 12 that includes the halo120. Thereafter, a distance between a bottom edge 301 of a meniscus atthe air/fluid interface within the syringe 12 and the bottom edge 303 ofthe halo 120 is measured by the system 110. These edges 301, 303 areidentified in the image by the software provided on the centralprocessing unit 116 from pixel contrast thresholds as described herein.FIG. 29 is an image obtained by sensor 114 of a syringe 12 containingsaline and FIG. 30 is an image obtained by sensor 114 where contrast ispresent in the syringe 12. As can be seen from these images, thedistance between edges 301 and 303 is greater (FIG. 29) when saline ispresent in the syringe compared to the distance between edges 301 and303 when contrast is present in the syringe (FIG. 30). With respect todifferentiation of contrast, the halo 120 will also be a different sizedepending on the type of contrast that is present in the syringe. Thisallows for differentiation of the type of fluid—saline, and variouscontrast agents—contained in the syringe using imaging processingtechniques as discussed in greater detail herein.

A distance from the bottom edge 301 of the meniscus between theair/fluid interface and the bottom edge 303 of the halo 120 isdetermined using the image processing software provided on the centralprocessing unit 116 as described herein. Then, this distance may becompared to various predetermined distances corresponding to variousfluids contained within the memory of the central processing unit 116.If the distance corresponds to the first predetermined distance forsaline, an indication 356 that saline is contained in the syringe 12 isautomatically displayed on the display 118, and if the distancecorresponds to the second predetermined distance for a specificcontrast, an indication 358 that the specific contrast is contained inthe syringe 12 is automatically displayed on the display 118.

Alternatively, pattern matching techniques based on the halo 120 sizemay be utilized to determine whether the syringe contains air, saline,or various contrast agents. For instance, the image processing softwareprovided on the central processing unit 116 can determine a height ofthe halo 120 from the bottom of the threads of nozzle 22 to the bottomedge of the halo 120 and determine the presence and fluid type based onthe height as described in detail herein. In addition, the imageprocessing software may also be programmed for specific contrast agentsor other fluids utilizing pattern recognition by taking a training imageof a syringe known to have a particular contrast contained therein. Thistraining image records all of the dimensions of the halo 120 includingheight. Then, the image processing software compares all of the featuresof later images it captures to the training image for comparison. If theimages exceed a threshold of similarity then the system will provide anindication that the syringe 12 contains contrast or saline other thanthe contrast it has been trained for.

2. Using Details Provided on the Barrel of the Syringe

An alternative approach to determining the type of fluid containedwithin a syringe using image processing techniques is to obtain an imageof certain features provided on the syringe. Specifically, and withreference to FIGS. 27, 31 and 32, the syringe 12 may include at leastone fluid dot 339 that is visible by the sensor through the air or fluidcontained within the syringe as described herein. Due to the differentproperties of air and different fluids, this dot 339 will have adifferent appearance, specifically along a horizontal axis, based on airor the fluid contained within the syringe as seen by comparing the fluiddot 339 of FIG. 27, seen through a syringe 12 containing air, the fluiddot 339 of FIG. 31, which is seen through a syringe 12 containingsaline, and the fluid dot 339 of FIG. 32, which is seen through asyringe 12 containing contrast. Accordingly, if air is contained withinsyringe 12, the fluid dot 339 will have a more shorter distance in thehorizontal direction when viewed by the sensor, if saline is containedwithin the syringe 12, the fluid dot 339 will have a certainconfiguration when viewed in an image and if contrast is containedwithin the syringe 12, the fluid dot 339 will have a certainconfiguration (i.e., longer distance in the horizontal direction) whenviewed in an image. Therefore, the type of fluid contained within thesyringe can be detected as follows.

First, the sensor 114 is positioned to capture an image of at least aportion of the syringe 12 that includes the fluid dot 339 or otherindicator feature on the syringe barrel through the fluid containedwithin the syringe 12. Thereafter, the fluid dot 339 is identified inthe image using pixel contrast thresholds as described herein. Next, atstep 344, since the shape of the fluid dot 339 when various fluids areprovided within the syringe are known, pattern matching techniques canbe utilized to determine whether air, saline or contrast is presentwithin the syringe 12. For example, a template of a fluid dot 339 whensaline is present within the syringe can be matched to the image. If thetemplate matches the image, it can be determined that saline is presentand an indication 356 that saline is present in the syringe 12 isprovided on the display 116. On the other hand, if the template does notmatch, a template of a fluid dot 339 when contrast is present within thesyringe can be matched to the image. If the template matches the image,it can be determined that contrast is present and an indication 358 thatcontrast is present in the syringe 12 is provided on the display 118.Further if the template for saline or various contrasts do not match, atemplate for a fluid dot 339 when air is present within the syringe canbe matched to the image. If air is determined to be in the syringe, theinjection procedure may be halted automatically.

Various other shapes, other than oval fluid dots 339, can be utilizedand imaged to determine the type of fluid contained within the syringeas described in greater detail herein.

3. Using Brightness Measurements

According to certain aspects, fluid differentiation may also be possibleby imaging a portion of syringe having electromagnetic radiation from asource thereof passing therethrough and determining the average pixelbrightness value of a region of interest, such as a portion of thedistal end 24 of the syringe. Returning to FIGS. 27, 29, and 30, whenthe syringe is filled with contrast (see FIG. 30), a distinct laser beampath 354 can be seen. The laser beam path 354 is much less distinct ifthe syringe 12 contains saline (see FIG. 29) and is essentiallyindiscernible when passing through a syringe filled with air. Accordingto certain embodiments, a laser that emits light having wavelengthswithin the green region of the visible light spectrum may be used.Accordingly, an average pixel brightness (e.g., 0-255 intensity units)in an image of the portion of the distal end 24 of the syringe 12 whenfilled with contrast is much higher than when the syringe is filled withsaline or air. Accordingly, the type of fluid contained within thesyringe can be determined by obtaining an image of the syringe throughwhich the electromagnetic radiation is being passed; determining aregion of interest of the syringe, such as near the distal end 24(although other regions of the syringe may be used); determining theaverage pixel brightness value for the region of interest by assigningeach 8 bit pixel within the region of interest a brightness value from0-255 intensity units then averaging these brightness values; andcomparing the average brightness value to a known brightness value todetermine whether contrast, saline, or air is present within the syringe12. This methodology may also be used to differentiate between differenttypes (e.g., brands or solute concentration) of contrast.

C. Fluid Source Status

According to other aspects, by using the at least one sensor 114 toobtain images of various portions of the fluid injector 10, variousinformation regarding the status of fluid sources can be obtained. Forexample, an image of a fluid container, such as a saline bag or contrastbottle, and its contents can be obtained and the amount of fluid withinthe bottle can be determined using image processing techniques. Thisinformation can be provided to the central processing unit and a bottlemay be displayed on display 118 illustrating the amount of fluid presentor remaining within the bottle. In addition, optical characterrecognition may be used to determine the type of fluid contained withinthe bottle and this information can also be displayed on the display118. Moreover, in certain aspects the fluid remaining in the bottle maybe constantly monitored prior to, during, and after an injectionprocedure and the updated remaining volume may be displayed real-time onthe display 118. In still other aspects, the central processing unit 116may monitor the remaining volume and provide a warning if the volume ofone or more of the contrast or saline are not sufficient to complete aninjection procedure. This feature may be combined with a patientschedule for a series of patients to provide real-time feed-back on therequired volume of contrast and/or saline so that a technician may besure to have sufficient supply on hand to complete all scheduledinjection procedures and may, for example when a contrast warmer isused, ensure that the subsequent container(s) of contrast is at thedesired injection temperature when the contents of the currently usedbottle are almost used up.

More specifically, the same methodology utilized for recognizing thesize of the halo 120 with pattern recognition techniques describedherein may be utilized for determining fluid source status. For example,the image processing software looks for geometrical components in theimage to compare to training images with known objects. In one example,if the image processing software is trained to know what the letters ofthe alphabet look like and the size and angular thresholds forrecognition are lowered, then the image processing software iseffectively able to read the label of the bottle and determine themanufacturer, contrast type, expiration dates, etc. Additionally, thefluid level within the bottle can be identified using edge detectiontechniques described herein and the image processing software can beprogrammed to calculate the volume remaining in the bottle until itneeds to be replaced by a user. This aspect utilizes similarcalculations as used with the volume of air present in the syringe asdescribed herein. Specifically, a curve may be generated and an equationfit for each of the bottle sizes and shapes or an algorithm may bedeveloped to determine remaining volumes.

D. Determination of Syringe Type (Size/Presence)

In certain aspects, the fluid verification system 110 may also beutilized to determine various properties or parameters of the syringe 12inserted into the injector, for example, syringe type, size,manufacturer, manufacturing date or lot number, suitability for aspecific injection procedure, prior use, remaining use lifetime, maximumpressure, etc., prior to a fluid injection procedure. This informationmay be used to identify the syringe and manufacturer, determine whetherthe syringe is previously used, and determine desired flow rates,pressures, volumes, etc. In one example, with reference to FIGS. 33 and34, the size of the syringe may be determined as follows. First, the atleast one sensor 114 is positioned to capture an image of at least aportion of the syringe 12 such as the distal end 24 of the syringe 12.Since the position of the at least one sensor 114 is known, the locationof certain features of a syringe 12 of a first size, such as the nozzle22 or the halo 120, and the location of certain features of a syringe 12of a second size, such as the nozzle 22 or the halo 120, in the image ofthe distal end 24 of the syringe are also known. Using this fact,pattern matching techniques can be utilized to determine the size of asyringe 12 used with the fluid injector 10. For example, a template 365of a syringe of a first size (e.g., 150 mL) can be applied to the image.If the template matches the image, the central processing unit 116 candetermine that the syringe is a 150 mL syringe and an indication 367 ofthe size of the syringe 12 is provided on the display 118. On the otherhand, if the template 365 does not match, a template 369 of a syringe ofa second size (e.g., 200 mL) can be applied to the image. If thetemplate matches the image, the central processing unit 116 candetermine that the syringe is a 200 mL syringe and an indication 367 ofthe size of the syringe 12 is provided on the display 118. If none ofthe stored templates match, an indication can be provided on the display118 that no syringe is present or that the syringe identity cannot bedetermined. In another aspect, the at least one sensor 114 may belocated in a position to image at least one identification marking onsyringe 12, such as a bar code containing information on the syringe,such as for example, manufacturer, manufacturing date or lot, one ormore syringe parameters, a specific identity/security code that can beconfirmed by the central processing unit to determine if the syringe isauthentic or is potentially being reused, etc., and transmit the imageof the identification marking to the central processing unit 116 fordeconvolution.

E. Tubing Presence Indicator

Similar to the determination of the syringe type, in other aspects thepresence or absence of a fluid path set 17 connected to the syringe 12can also be determined using imaging processing techniques. Thisinformation can be utilized by the central processing unit 116 todisable the injector if an operator inadvertently attempts to start aninjection procedure without a fluid path set 17 being connected to thenozzle 22 of the syringe or if the fluid path set has not been primed.In one example, with reference to FIGS. 35 and 36, the sensor 114 ispositioned to capture an image of the nozzle 22 of the syringe 12. Sincethe position of the sensor 114 is known, the location of certainfeatures of the syringe 12, such as the nozzle 22 and the fluid path set17, if connected to the nozzle 22, in the image of the syringe 12 arealso known. Using this fact, pattern matching techniques can be utilizedto determine whether a fluid path set 17 is connected to the syringe 12.For example, a template 373 of a syringe 12 having a fluid path set 17connected thereto can be applied to the image. If the template matchesthe image, the central processing unit 116 can determine that the fluidpath set 17 is connected to the syringe 12 and an indication 375 thatthe fluid path set 17 is present is provided on the display 118 (seeFIG. 31). On the other hand, if the template 373 does not match, thecentral processing unit 116 can determine that no fluid path set 17 ispresent and an indication 377 that no fluid path set 17 is present isprovided on display 118.

F. Spike or Transfer Set Presence Indicator

With reference to FIG. 37, according to certain aspects, a fluidtransfer device 46 is often used to fill a syringe 12 from a fluidcontainer 44. The transfer device 46 typically includes a spike 48having at least one fluid path, and in certain aspects an air passage,for puncturing the seal of the fluid container 44, a container holder orcup 50 for holding the fluid container 44 on the spike 48, a valve (notshown), such as a check valve, for allowing fluid to enter the syringe12 and a syringe support member or sleeve 54 for holding the syringe 12in relationship to the transfer device 46.

During a filling procedure, after the syringe 12 is mounted on the fluidinjector 10, the plunger 26 is advanced to expel air from the syringe12. The syringe 12 is then ready to be filled with fluid. The transferdevice 46 may then be inserted onto the fluid container 44 such that thespike 48 pierces the seal of the fluid container 44. The syringe supportmember 54 of the transfer device 46 may then be placed over the nozzle22 of the syringe 12. Within the support member 54, the luer tip of thesyringe 12 engages and actuates the valve to open a passage for fluid toflow from the container 44 to the syringe 12. To aspirate the contentsof the fluid container 44 into the syringe 12, the injector piston (notshown) retracts the plunger 26 of the syringe 12. After filling thesyringe 12, the fluid container 44 is removed from the transfer device46. Filling of the syringe with fluid may be monitored, for example inreal-time, by the at least one sensor 114 to ensure accurate filling ofthe syringe.

Once filling is complete, it may be desirable for the operator to beprovided with an indication of whether the fluid transfer device 46 hasbeen removed. This can be automatically done using the fluidverification system 110 described herein. Specifically, with referenceto FIGS. 38 and 39, the at least one sensor 114 is positioned to capturean image of the nozzle 22 of the syringe 12. Since the position of theat least one sensor 114 is known, the location of certain features ofthe syringe 12, such as the nozzle 22 and the fluid transfer device 46,if connected to the nozzle 22, in the image of the syringe 12 are alsoknown. Using this fact, pattern matching techniques can be utilized todetermine whether a fluid transfer device 46 is connected to the syringe12. For example, a template 383 of a syringe 12 having a fluid transferdevice 46 connected thereto can be applied to the image. If the templatematches the image, the central processing unit 116 can determine thatthe fluid transfer device 46 is connected to the syringe 12 and anindication 385 that the fluid transfer device 46 is present is providedon the display 118 (see FIG. 38). This information may also be displayedon a touch screen controller 82 of a fluid injection system 600 as shownin FIG. 58. On the other hand, if the template 383 does not match, thecentral processing unit 116 can determine that no fluid transfer device46 is present and an indication 387 that no fluid transfer device 46 ispresent is provided on the display 118 (see FIG. 39).

G. Tubing Purged Indicator

With reference to FIG. 40, in certain aspects of the fluid injectors 10described herein, a purge container 550 may be configured to beconnected to the end of a connector 552 of the fluid path set 17 thatdelivers contrast media or other fluid to a patient during a purgingprocedure prior to an injection. When the fluid path set 17 is primed orpurged of air prior to an injection procedure, the purge container 550may collect the discharge of contrast media from the end of the fluidpath set 17 that delivers the media to the patient when the syringe 12and fluid path set 17 are purged and primed and provide an indicationthat the purge is acceptable based on the amount of contrast containedtherein. In certain aspects, an operator may visually inspect the purgecontainer 550 to determine that an acceptable amount of contrast iscontained therein and that the purge was acceptable and the syringe andfluid path are primed with fluid. However, in certain aspects thisprocess may be automated by capturing an image of the purge container550 with the at least one sensor 114 and processing the image using theimage processing techniques discussed herein.

For instance, with reference to FIGS. 41, 42A, and 42B, a fluid dot 554or other indicator marking, similar to the fluid dot 339 discussedherein, may be formed or provided on a surface of the purge container550. The at least one sensor 114 is positioned such that it will imagethe fluid dot 554 through any fluid contained within the purge container550. Due to the different properties, such as index of refraction, ofdifferent fluids and/or the selected curvature of the purge container550, this dot 554 will have a different appearance based on the fluidcontained within the syringe and purge container 550. Accordingly, ifair is contained within the purge container 550, the fluid dot 554 willhave a first configuration when viewed in an image, for exampleaccording to one aspect as shown in FIG. 42A and, if a fluid, such ascontrast or saline, is contained within the purge container 550, thefluid dot 554 will have a second configuration, for example as shown inFIG. 42B. The configuration of the fluid dot 554 can be detected asfollowed. First, the at last one sensor 114 is positioned to capture animage of at least a portion of the purge container 550 that includes thefluid dot 554 through the fluid contained within the purge container 550after the syringe and tubing set 17 have been primed and purged of air.Thereafter, since the shape of the fluid dot 554 when various fluids areprovided within the purge container 550 are known, pattern matchingtechniques can be utilized to determine whether air or fluid is withinthe purge container 550. Accordingly, a template of a fluid dot 554 whena certain fluid, such as contrast or saline, is present within the purgecontainer 550 can be matched to the image of the fluid dot 554 obtainedby the sensor 114. If the template matches the image, it can bedetermined that no air is present in the syringe and tubing set 17 andthat purge container 550 contains sufficient fluid to indicate that thesystem has been primed and a signal can be sent to the fluid injector 10that the fluid path set 17 has been properly purged and primed. Anindication may also be provided on display 118 that the fluid path set17 has been properly purged and primed and that the injector is readyfor the injection procedure. According to certain aspects, the primingand purging of the syringe and fluid path set may be monitoredreal-time. In this aspect, the at least one sensor 114 monitors thefluid dot 554 on purge container 550 as the configuration of the fluiddot 554 changes during the priming procedure, thus monitoring the changein volume of the purge container 550 and indicating when sufficientfluid has been primed into the system and no additional air remains inthe system. According to one aspect, an algorithm may be utilized thatcorrelates volume change in purge container 550 with fluid flow throughtubing set 17 to confirm completion of the priming operation.

Alternatively according to another aspect, with reference to FIGS. 43Aand 43B, rather than using a fluid dot 554, one or more reference lines556 may be formed or provided on a surface of the purge container 550.The reference line 556 may be printed on the surface of the purgecontainer 550, molded onto the surface of the purge container 550, orformed or provided on the surface of the purge container 550 in anyother suitable manner. The at least one sensor 114 is positioned suchthat it will image the reference line 556 through any fluid containedwithin the purge container 550. Once an image of the purge container 550is obtained, the image processing software provide on central processingunit 116 identifies a top edge 558 of the fluid F contained within thepurge container 550 along with the reference line 556 using pixelcontrast thresholds as described herein. A distance 560 from the topedge 558 of the fluid F contained within the purge container 550 to thereference line 556 is determined using the image processing softwareprovided on the central processing unit 116. The central processing unit116 compares this distance 560 to various predetermined distancescorresponding to acceptable and unacceptable purging processes todetermine if the purge is acceptable and the system is primed. Again,the purge/prime operation and change in volume in the purge container550 may be monitored real-time as the syringe and fluid path set 17 areprimed to ensure accurate priming of the system.

In yet another alternative, with reference to FIGS. 44A and 44B, anindicator line 562 having the shape shown may be formed or provided on asurface of the purge container 550. The indicator line 562 may beprinted on the surface of the purge container 550, molded onto thesurface of the purge container 550, or formed or provided on the surfaceof the purge container 550 in any other suitable manner. The sensor 114is positioned such that it will image the indicator line 562 through anyfluid contained within the purge container 550. Due to the properties ofdifferent fluids and/or the selected curvature of the purge container550, the indicator line 562 appears to be a different length in an imagewhen fluid is present as compared to when air is present. In addition,the indicator line 562 may have a brighter appearance when viewed in airthan when viewed in fluid. Accordingly, pattern matching techniquesand/or brightness level measurement of the indicator line 562 can beperformed on an image of the indicator line 562 by the image processingsoftware on the central processing unit 116 to determine whether fluidor air is present within the purge container 550. Based on thisdetermination, the central processing unit 116 can determine theacceptability of the purge and provide an indication, via display 118,to an operator. Again, the purge/prime operation and change in volume inthe purge container 550 based on changes in indicator line 562 may bemonitored real-time as the syringe and fluid path 17 are primed toensure accurate priming of the system. One of skill in the art willrecognize that other configurations of the indicator line 562 arepossible and that the image recognition software and algorithmsdescribed herein may monitor changes in the configuration of theindicator line 562 during a purging/priming operation and indicate tothe technician that the system has been correctly primed and is readyfor use in an injection procedure. Such other configurations are withinthe scope of this disclosure.

With reference to FIG. 45, an alternative configuration of the purgecontainer 550 is illustrated. This purge container 550 is alsoconfigured to be connected, during a purging procedure, to the end of aconnector 552 of the fluid path set 17 that is designed to delivercontrast media or other fluid to a patient during a subsequentdiagnostic injection procedure. The purge container 550 includes acylindrical body 563 having a proximal end 564 and a tapered distal end565 similar to the tapered distal end 24 of the syringe 12 describedherein. An electromagnetic radiation source 566, such as an LED, ispositioned beneath the proximal end 564 of the cylindrical body 563.Accordingly, when the purge container 550 is filled with an appropriateamount of fluid, a halo 567 is generated similar to the manner in whichhalo 120 is formed within the syringe 12 as described herein. Thisallows the operator to quickly and easily determine if an acceptableamount of contrast is contained therein and that the purge wasacceptable if the halo 567 is present and that the syringe and fluidpath set 17 are appropriately primed. In addition, this process may beautomated, and in certain aspects monitored real-time, by capturing oneor more image of the halo 567 generated within the purge container 550with at least one sensor 114 and processing the image using the imageprocessing techniques discussed herein.

With reference to FIG. 46, according to an aspect, the fluid path set 17may be altered to allow for image recognition of an image of the tubingobtained by at least one sensor 114 to determine whether the fluid pathset 17 has been sufficiently purged. For example, as shown in FIG. 46,the tubing of the fluid path set 17 may include a fiber optic cable 610positioned adjacent thereto. The fiber-optic cable 610 may also beco-extruded with the tubing of the fluid path set 17 such that thefiber-optic cable 610 is embedded within the tubing or it may be placedinside the tubing of fluid path set 17. In another example, a reflectivesurface may be provided on the inside or the outside of the tubing ofthe fluid path set 17 to transmit light via internal reflectionthroughout the tube length or alternatively the fluid path material maybe selected to have an index of refraction suitable for internalreflection as described herein. This will allow light to be reflectedthroughout the length of the tubing of the fluid path set 17 when fluidis present (similar to how a light pipe works) and result in a visibleindicator that the tubing of the fluid path set 17 is purged and filledwith fluid. This visual indicator can be an illuminated component at theend of the tube set which can be recognized by the sensor 114 or simplyby the operator. If air is present in the fluid path set 17, for examplewhen the tubing has not been totally primed, internal reflection of thelight will not occur and the “light pipe” effect will not be observed.

Furthermore, the tubing of the fluid path set 17 can be configured tohave a connector (not shown) on the end thereof that is attached to theinjector 10 or positioned in a location where an electromagneticradiation source is emitting through a section of the connector. Theentire connector would only light up according to this embodiment if itis full of fluid indicating that the tubing of the fluid path set 17 iscompletely purged of air and is primed and ready for use. Theelectromagnetic radiation source may be wireless, battery powered, orconnected to a power source on the injector. This means that it can haveeither direct or indirect contact with the tubing of the fluid path set17 and can be either disposable or re-usable according to specificaspects.

In yet another example, the image processing software provided on thecentral processing unit 116 can be used to determine the volume of fluidrequired to purge the fluid path set 17. More specifically, the systemcan determine how much air is present within the syringe 12 using any ofthe methods described herein. Thereafter, the image processing softwareon the central processing unit 116 can determine the type of fluid pathset 17 connected to the syringe using pattern matching techniques asdescribed herein. Using this information, the central processing unit116 can calculate the volume of fluid required to purge/prime the fluidpath set 17. Using this information, the central processing unit 116 mayinstruct the injector 10 to operate the syringe to move the plunger asufficient distance corresponding to the volume of air calculated to bein the syringe and fluid path set 17. The plunger may be moved anadditional distance to eject a further volume to ensure complete primingof the system.

In another configuration of the purge container 550, one or more sensorsmay be associated therewith. More particularly, a component (not shown)may be provided in the purge container 550 that moves when fluid enters(meaning the tubing is being purged). The moving component may bedetected by the sensor 114 or be a visual indicator for the operator anda volume of fluid coming into the purge container 550 may be determinedto confirm when priming of the syringe and fluid path set 17 iscomplete.

For example, in one aspect, the component could be an air filter (e.g. aPorex brand filter) which allows air to pass through as the priming istaking place and then is contacted by the fluid, builds up pressure,breaks friction with the surface and is driven forward to a positionthat can be detected by sensor 114 or the operator. The component couldalso be floating balls which rise and fall relative to the presence andthe density of the fluid present, discussed in detail herein with regardto positioning such balls in the syringe.

H. Capacitance Measurement Based on Swell and Stretch of at Least aPortion of the Syringe

Capacitance is defined as the change in volume of a fluid path element,elements, or the whole system as a result of a change in pressure on thesystem, for example when the internal pressure of the system isincreased by operation of the plunger to pressurize the system during aninjection process. Total system expansion volume, capacity, orcapacitance volume represents the total amount or volume of suppressedfluid (i.e., backflow volume) that is captured in the swelling of theinjector system components due to the applied pressure. Total systemcapacitance and capacitance volume is inherent to each fluid injectionsystem and depends on a plurality of factors, including injectorconstruction, mechanical properties of materials used to construct thesyringe, piston, pressure jacket surrounding the syringe, pressurejacket and restraint movement or flexing, fluid density,compressibility, and/or viscosity, change in flow volume under constantpressure, fluid lines delivering the contrast and saline to a flowmixing device, the starting pressure, the ending pressure, etc. Forexample, in dual syringe injectors, the amount of back or reverse flowincreases when the relative speed difference between the two pistons ofthe injection system is large and the pressure required is high, whichcan occur when the simultaneous fluid flow is through a smallrestriction, the speed of the total fluid injection is large, and/or theviscosity of the fluid is high. The back or reverse flow can preventdifferent ratios of simultaneously delivered fluid from ever occurringin certain injections, which can be a detriment for all two-syringe typeinjector systems, such as fluid injector 10.

Capacitance measurement can be used to correct for changed flow rate andvolume delivered dynamically to enhance clinical imaging practices. Morespecifically, in medical procedures, such as in the intravenous infusionof a contrast medium for contrast-enhanced radiographic imaging, it isoften desirable to introduce a “sharp bolus” of fluid in which themedication and/or diagnostic fluid is introduced at increased pressurefor rapid delivery into a specific location within the body. In the caseof contrast-enhanced radiographic imaging, sufficient contrast mediamust be present at the specific location or region of interest in thebody at a predetermined time for diagnostic quality images to be takenduring the procedure. Therefore, accuracy in the amount or volume ofcontrast media delivered to the patient and the time at which thisvolume of contrast media reaches a particularly point in the body of apatient is important. A “sharp bolus” of contrast media in practice maybe defined as a distinct or defined column of liquid having well-definedopposing ends or boundaries. Accordingly, accuracy in the amount offluid delivered intravenously to a patient is often of importance inmedical therapeutic and diagnostic procedures and such accuracy can bediminished by capacitance volume expansion of the fluid delivery pathcomponents when the fluid delivery system is under pressure. Furtherdetails of capacitance measurement and capacitance correction isdescribed in U.S. Pat. No. 8,403,909 to Spohn et al., which is herebyincorporated by reference in its entirety.

With reference to FIG. 47, as a fluid is delivered portions, of thesyringe 12 will swell and stretch due to increase in internal pressureduring an injection procedure. According to aspects of the presentdisclosure, the capacitance volume can then be determined as follows.This swell and stretch can be detected real-time by the at least onesensor 114 and the extent thereof can be measured using the imageprocessing software provided on the central processing unit 116. Forinstance, the outside diameter of the syringe 12 along the length of thebarrel 18 of the syringe 12 can be determined as shown in FIG. 47. Thecentral processing unit 116 can then integrate across the differentouter diameter measurements along the length of the barrel 18 above thebottom seal of the plunger 26 to determine an accurate volume within thesyringe 12 dynamically. Thereafter, the expected volume if the syringe12 had no capacitance is subtracted from the determined dynamic volumeand this results in a remaining volume which corresponds to thecapacitance volume. Once a capacitance volume is known, fluid injector10 can be controlled to control piston 124 to compensate for expansionof barrel 18 under pressure ensuring delivery of a sharp bolus.

With reference to FIG. 48, a volume versus time graph of an injectionprocedure performed by fluid injector 10 is illustrated in which line501 represents a volume of fluid the fluid injector 10 has beenprogrammed to believe has been delivered absent any correction forcapacitance; line 503 represents the volume of the fluid that hasactually been delivered to the patient; and line 505 represents thedifference due to system capacitance between what is believed to havebeen delivered and what has actually been delivered. The scanner (notshown) used to capture an image for diagnostic purposes is activated andinstructed to start capturing images at the exact time interval the drugis expected to be passing through the particular part of the body thatis desired to be imaged. That time is based on the amount of fluid thefluid injector 10 believes is being introduced over a certain period oftime (i.e., line 501 in FIG. 48). Since the actual amount of fluid isdelivered later than expected, the scanner may in certain instancescapture images when the fluid (i.e., contrast) is not fully introducedinto the part of the body being imaged. This is due to the capacitance,or swelling of the syringe and tube set with pressure as describedherein. To correct for this, most operators introduce an estimated delayto try to compensate for capacitance. However, by determining the flowrate and the capacitance based on swell and stretch sections asdescribed herein, the controller of the fluid injector 10 can automatethis delay for the operator and capture the best quality images fordiagnostic purposes.

I. Determination of Volume Remaining

In one example, the fluid verification system 110 may be arranged suchthat the at least one sensor 114 can capture an image of the syringe 12that includes the syringe barrel 18 and the plunger 26 such that aposition of the plunger 26 in each of the images can be determined.Based on these images, the volume of contrast or saline remaining withinthe syringe 12 can be determined. Specifically, with reference to FIG.49, an image of the syringe 12 is obtained by the sensor 114 at step570. Then, at step 572, the image processing software identifies theplunger 26 in the image by using pattern recognition based on a trainingimage as discussed herein. Next, at step 574, the image processingsoftware determines the position of the plunger 26 within the barrel 18of the syringe 12 by determining the change in location of the plunger26 relative to a reference point. Once the position of the plunger 26within the barrel 18 of the syringe 12 has been determined, thisposition can be compared to known positions corresponding to a volume offluid remaining within the syringe 12 at step 576. The centralprocessing unit 116 then sends a signal to display the volume remainingto the display 118 at step 578. The volume remaining may be displayed asa numerical value or a graphical representation of the syringe 12 may bedisplayed that illustrates the real-time volume remaining within thesyringe. Images are continuously taken and the display of volumeremaining is continuously updated until the injection procedure iscomplete as determined at step 580. Correction of remaining syringevolume by measurement of syringe expansion during injection due tocapacitance may also be incorporated into the protocol. Accordingly, theat least one sensor may measure the change in outer diameter of thesyringe, for example by comparison of an image to a reference template,and calculate the volume due to capacitance. This capacitance volume maybe monitored real-time and transmitted to the central processing unitwhere algorithmic analysis may allow compensation for capacitance toadjust the fluid delivery and provide for delivery of a sharp bolus.

In an alternative example, the volume remaining in the syringe 12 can bedetermined using only an image of the halo 120 if the plunger 26 ofFIGS. 5A and 5B is utilized. More specifically, the plunger 26 can beformed from or coated with a reflective material having a plurality ofdifferent colored stripes 38. The reflective material forming thestripes 38 reflect light directed toward the plunger 26 in the distaldirection through the syringe barrel 18 to produce the halo. As theplunger or plunger cover 26 moves through the barrel, light reflectsfrom a different stripe 38 depending on the position of the plunger 26within the syringe barrel 18. Since each of the stripes 38 of theplunger 26 is different in color, the color and/or appearance of thehalo changes depending on the stripe 38 upon which the light isreflected as the plunger 26 advances or retracts through the syringebarrel 18 during an injection or filing procedure. The at least onesensor 114 may be positioned to capture images of the halo as theplunger advances or retracts through the syringe barrel 18. The imageprocessing software provided on the central processing unit 116 detectsthe change in color of the halo. The central processing unit isconfigured to then determine a position of the plunger 26 within thesyringe barrel 18 based on the color of the halo. Once the centralprocessing unit 116 determines the position of the plunger 26, thevolume of fluid remaining within the syringe is determined. The centralprocessing unit 116 then sends a signal to display the volume of fluidremaining on the display 116. The volume of fluid remaining may bedisplayed as a numerical value or a graphical representation of syringe12 may be displayed that illustrates the volume remaining within thesyringe. In an alternative embodiment, different colored LED lights maybe located in the piston to transmit light through atranslucent/transparent plunger material in similar concentric circleson the plunger.

J. Pressure Feedback Based on Swell and Stretch of the Syringe

In another example, image processing techniques may be utilized todetermine the pressure at which a fluid within the syringe 12 is beingdelivered to a patient during a fluid injection procedure due to thefact that portions, such as a portion of the distal end 24, of thesyringe 12 will swell and stretch during an injection procedure. Theextent of this swell and stretch may correspond to the pressure that thefluid exerts within the syringe at a given time.

With reference to FIGS. 50 and 51, according to one embodiment, in orderto enhance this swell and stretch, an alternative example of the syringe12 having a flexible section 590 positioned at a distal end 24 thereofmay be utilized. Many components of the syringe 12 shown in FIGS. 50 and51 are substantially similar to the components of the syringe 12described herein with reference to FIG. 2. Reference numerals in FIGS.50 and 51 are used to illustrate identical components as thecorresponding reference numerals in FIG. 2. As the previous discussionregarding the syringe 12 generally shown in FIG. 2 is applicable to theaspect shown in FIGS. 50 and 51, only the relevant differences betweenthese systems are discussed herein.

In one aspect, the flexible section 590 may be configured to expand whenthe internal pressure of the syringe 12 increases during an injectionprocedure. The flexible section 590 may be insert molded from a moreflexible material than the syringe barrel 18. The material forming theflexible section 590 may be any suitable flexible material such as, butnot limited to TPU, TPE, polypropylene, polyethylene, and, thermoplasticelastomers. In addition, flexible material 590 may be a transparent ortranslucent material which when illuminated with electromagneticradiation source 112 shows a halo feature described herein.

While the flexible section 590 is illustrated in FIGS. 50 and 51 asbeing positioned at the distal end 24 of the syringe 12, this is not tobe construed as limiting the present disclosure, as flexible section 590may be applied to many areas of syringe 12. Factors to consider includeminimizing fluid capacitance while maximizing swell for better pressureresolution.

With reference to FIGS. 52 and 53 and continued reference to FIGS. 50and 51, the fluid verification system 110 comprising the at least onesensor 114, central processing unit 116, and display 118 according tothis aspect may be positioned such that the sensor 114 is capable ofcapturing an image of the flexible section 590 during an injectionprocedure. Once an image of the flexible section 590 is obtained, theimage processing software of the central processing unit 116 measures anincreased diameter of the flexible section 590 and correlates theincreased diameter with syringe internal pressure. For example, FIG. 52illustrates the flexible section 590 having a small increase in diameterthat corresponds to a small syringe internal pressure while FIG. 53illustrates the flexible section 590 having a large increase in diameterthat corresponds to a large syringe internal pressure. Centralprocessing unit 116 may display this syringe internal pressure ondisplay 118 and control fluid injector 10 to allow active pressurecontrol within the syringe during injections.

Accordingly, the flexible section 590 provides a “live” or real-timereadout on pressure within the barrel 18 of the syringe 12 during aninjection procedure. With reference to FIG. 54, the negative pressurecreated during a filling procedure causes the flexible section 590 tomove inward. The dimensional changes of the flexible section 590 can bemeasured using the sensor 114 and image processing software provided onthe central processing unit 116 and the subsequent vacuum level canthereafter be determined.

Such negative pressure may be important to the rolling diaphragm syringe135 described herein because having a high vacuum level during a fill ofsuch syringe 135 could crush or deform the walls of the syringe 135.Accordingly, with reference to FIG. 55, one embodiment of the rollingdiaphragm syringe 135 may be adapted to include a flexible section ordiaphragm 591 on a connector 592 attached to the distal end 137 of therolling diaphragm syringe 135 or provided in the cap 390 (not shown).The outer diameter of the flexible section 591 can be measureddynamically in real-time using the at least one sensor 114 and imageprocessing software provided on the central processing unit 116 asdescribed herein with regard to the measurement of the diameter of theflexible section 590. The outside diameter of the flexible section 591decreases as the vacuum within the rolling diaphragm syringe increasesduring a filling procedure. Therefore, the size of the outside diameterof the flexible section 591 can be used to determine the vacuum levelwithin the rolling diaphragm syringe 135. Thereafter, vacuum level canbe maintained under a specified threshold by adjusting the rate at whichpiston 138 is withdrawn to prevent crushing of the rolling diaphragmsyringe 135.

With reference to FIGS. 56A and 56B, according to an aspect, adetermination of the pressure within the syringe 12 can also be obtainedby positioning the electromagnetic radiation source 212 such that itreflects through at least a portion of a sidewall of the syringe barrel18. Light that shines through the sidewall of the syringe barrel 18 isvisualized at the bottom of the halo 120 as shown by the lines 121 a and121 b. For example, if there is no light shining up the sidewall of thesyringe barrel 18, this area will appear as a black line (121 b).Placing the electromagnetic radiation source 212 underneath the syringe12 facing up towards the sidewall of the syringe barrel 18 causes theline at the bottom of the halo 120 to appear lit up (see element 121 ain FIG. 56A) because the light travels up the interior of the sidewallof the syringe barrel 18 and is portrayed in the halo 120.

As the syringe 12 is subjected to pressure for example during aninjection procedure, it swells, pushing the walls of the syringe 12outward as shown in FIG. 56B. This removes the straight-line path forthe light from the electromagnetic radiation source 212 to the bottom ofthe halo 120. This line fades from light to dark as the syringe 12swells (i.e., pressure increased) (see element 121 b in FIG. 56B). Theelectromagnetic radiation source 212 may also be placed such that thelight would completely disappear when the pressure limit of the syringewas reached (i.e., the syringe swells enough to block the light).Alternatively the brightness could be determined as a function ofpressure (i.e., swelling) and be used to determine pressure. Forexample, image recognition software may be used to monitor change inintensity of the line to provide real-time feedback on syringecapacitance.

K. Flow Rate Feedback

Feedback regarding the flow rate of the fluid delivered by the fluidinjector could also be provided to an operator using many of theconcepts described herein. More specifically, the position of theplunger 26 axially within the syringe barrel 18 can be monitored by thesensor 114 and the image processing software during an injectionprocedure. Thereafter, a curve can be created showing the position ofthe plunger relative to the time during the injection procedure. Anequation to fit the curve can then be derived. The equation is thenprovided to a logic algorithm in which the data from the curve isembodied to calculate the flow rate of fluid being delivered by theinjector. This flow rate can be displayed to the operator on display118.

L. Syringe Filling Feedback

When filling the syringe 12, with contrast or saline, it has beenobserved that the halo or illuminated identification pattern 120described in detail herein is only present if the syringe is beingfilled at a proper rate. For example, using a syringe such as thesyringe 12, the proper fill rate is about 4 mL/sec because this is thefastest fill rate with the thickest fluid that can be achieved before avacuum head is drawn into the syringe. However, the fastest specifiedfill rate will depend upon the particular restrictions of the fluidinjection system at issue. The piston should be drawn back such that thesyringe is filled in the fastest possible manner depending on the fluidinjection system that is being utilized. This is accomplished using theconcepts described herein by dynamically examining the halo 120 usingthe sensor 114 and the image processing software provided on the centralprocessing unit 116 during a filling procedure. As long as the halo 120is determined to be completely present then the vacuum has not reached athreshold where a vacuum head (i.e., air) is generated in the syringe.The halo 120 is recognized using the sensor 114 and the image processingsoftware provided on the central processing unit 116 as described hereinand the position of the top edge of the halo 120 relative to the bottomedge of the halo 120 is detected. If the top edge of the halo 120 beginsto move downward, an indication that air is being pulled into thesyringe 12 can be provided to the operator. In addition, the fluidinjector 10 can be controlled to adjust the rate at which the piston 124is drawing the plunger 26 back to reestablish the appropriate size ofthe halo 120. This allows the fluid injector 10 to achieve the fastestpossible fill rate independent of the size of the syringe, the fluidtype, or the fill rate.

In other words, if the syringe is being filled too fast, which leads toair being introduced into the syringe, the halo 120 will not be present.Accordingly, the sensor 114 can be positioned to capture an image of thehalo 120 during a filling procedure. The image processing software ofthe central processing unit 116 processes the image to determine thepresence of the halo 120. If an absence of the halo 120 results, asignal is sent to the fluid injector 10 to stop the filling process andadjust the rate at which the piston rod 124 retracts the plunger 26 sothat the halo 120 is present throughout the filling process.

M. Other Features of the Syringe that May be Identified with ImageProcessing

Several other features of the syringe 12 may be imaged using the fluidverification system 110 and information obtained thereby may be providedto the fluid injector 10. For example, it is often necessary for theoperator or technician to validate the syringe prior to performing theinjection. Validation may include confirming that the syringe isacceptable for the injector and determining various characteristics ofthe syringe and fluid contained therein. For example, the operator mustverify that identifying information, such as the syringe dimensions(e.g., diameter, length, and fluid volume), and fluid contents arecorrect for the procedure being performed. In addition, the operator maybe required to provide certain information about the syringe, such asthe date of manufacture, source, frictional characteristics between theplunger and syringe barrel, fluid viscosity, and the like (referred togenerally herein as “syringe injection parameters”) to the fluidinjector or the injector operating system to control piston force andacceleration to deliver fluid at a desired flow rate. The identifyinginformation may be contained on or associated with a machine readableidentification tag, such as a barcode. Accordingly, an image of such abarcode may be obtained by the sensor 114. The image processing softwareprovided on the central processing unit 116 may then be configured toread the identifying information from the barcode and provide thisinformation to the fluid injector 10. In certain examples, the barcodemay be backlit by the electromagnetic radiation source 112, therebymaking it more clearly visible to the sensor 114.

In addition, the cylindrical syringe barrel 18 is, in effect, a lensitself. Utilizing the curvature of the barrel wall, images that arecaptured and recognized appear different to the image processingsoftware provided on the central processing unit 116 if there is air inthe syringe 12 or if fluid is present in the syringe 12. If there is airin the syringe 12, the image of the barcode received by the sensor 114appears in a first size and/or orientation. If there is fluid present inthe syringe 114, the image of the barcode appears in a second size andis inverted. Accordingly, in one example, the barcode may be encodedwith information such that when it is read by the sensor 114 when thereis air in the syringe 12, the code informs the system that the syringe12 is present, the size of the syringe 12, and that air is present inthe syringe 12. When fluid is present within the syringe 12, the barcodeimage inverts and the image processing software provided on the centralprocessing unit 116 recognizes the new code which provides a signal tothe system indicating that fluid is present within the syringe 12.Furthermore, the relative size of the barcode provides an indication ofthe fluid type within the syringe 12 (i.e., saline, contrast, or thetype of contrast).

In another example, with reference to FIG. 57, a temperature strip 58may be added to the syringe 12 to provide an indication of thetemperature of the contents of the syringe 12 to an operator. Thistemperature strip 58 may be imaged by the sensor 114 and automaticallyread by the image processing software. Specifically, the sensor 114 ispositioned to capture an image of the temperature strip 58 on thesyringe barrel 18. The temperature strip 58 is configured to changecolor with temperature or have some other method that indicates thetemperature. The image processing software is configured to detect thischange in color and determine the temperature based on the change incolor. Thereafter, the temperature information may be provided to thefluid injector. In certain examples, temperature strip and barcode mayboth be provided on a label applied to the syringe 12.

N. Exemplary Fluid Injection System Utilizing Image RecognitionTechniques

With reference to FIGS. 58-60, an exemplary fluid injection system 600comprises a fluid injector 10 that may have a housing 14 formed from asuitable structural material, such as plastic, a composite material,and/or metal. The housing 14 may be of various shapes and sizesdepending on the desired application. For example, the fluid injectionsystem 600 may be a freestanding structure having a support portion 70connected to a base 72 with one or more rollers or wheels such that thefluid injector 10 is movable over the floor. The fluid injector 10 mayinclude at least one syringe port 16 for releasably connecting the atleast one syringe 12 to respective piston rods 124. In various examples,the at least one syringe includes at least one syringe retaining memberconfigured for retaining the syringe within the syringe port 16 of thefluid injector 10. In non-limiting examples, the at least one syringeretaining member is configured to operatively engage a locking mechanismprovided on or in the syringe port 16 of the fluid injector 10 tofacilitate self-oriented loading and/or removal of the syringe to andfrom the injector 10. The syringe retaining member and the lockingmechanism together define a connection interface for connecting thesyringe to the fluid injector 10. An example of various connectioninterfaces is described in U.S. Pat. No. 9,173,995.

In certain non-limiting examples, it is desirable to temporarily rotateand/or invert the injector housing 14 including syringe ports between asubstantially vertical position (i.e., with the syringe port(s) pointingupwards), which may facilitate, for example, the loading of a syringeinto a syringe port or the filling of a syringe with medical fluid, andan inverted position, which may facilitate, for example, the removal ofair bubbles in a medical fluid contained within a syringe, or theconducting of an injection procedure. Accordingly, in non-limitingexamples, housing 14 may be connected to support portion 70 in arotatable fashion such that housing 14 is rotatable relative to thesupport portion 70 and retractable pole 74.

The fluid injection system 600 may further include a lower supportmember 76 that may be extended or retracted in a vertical direction toadjust the height of the fluid injector 10. An operator may push down ona handle 78 to release a locking connection between the lower supportmember 76 and a fluid warmer 80 provided on the lower support member 76.As the handle 78 is pressed down, the operator can lift or lower thefluid warmer 80 to adjust the height of the fluid injector 10.

In non-limiting examples, at least one fluid path set 17 may be fluidlyconnected with the distal end of the at least one syringe for deliveringmedical fluid from the at least one syringe to a catheter, needle, orother fluid delivery connection (not shown) inserted into a patient at avascular access site. Fluid flow from the at least one syringe may beregulated by a fluid control module operated by a controller, such as adetachable touch screen controller 82 or any suitable device. The fluidcontrol module may operate various pistons, valves, and/or flowregulating devices to regulate the delivery of the medical fluid, suchas saline and contrast, to the patient based on one or more userselected injection parameters, such as injection flow rate, duration,total injection volume, and/or ratio of contrast media and saline.

The controller 82 may include one or more processors, memory, networkinterfaces, and/or the like and may be configured to control a displaycomprising a graphical user interface (“GUI”), which may allow a user toview and/or interact with various injection parameters through graphicalicons and visual indicators produced on the display. The controller 82may include the central processing unit 116 having the image processingsoftware provided thereon or on a separate unit. In non-limitingexamples, the controller 82 may be formed as a detachable touch screencontroller. The controller 82 may also be non-removably attached to thefluid injector 10. The controller 82 may be used to monitor one or moreinjection parameters, including, for example, patient specificinformation (age, weight, sex, organ to be imaged, dosage of imagingagent, etc.), which may be inputted by the user or recalled/downloadedfrom a database, a network, a memory, or another controller incommunication with the system by a wired or wireless communicationprocess. The controller 82 may be further configured to control variousinjection parameters which may be inputted by a user and/or calculatedby one or more algorithmic calculations performed by the controller 82,the fluid control device, and/or another controller or processor incommunication with the fluid control device and/or the controller 82based on data downloaded from a database and/or inputted by a user.

With specific reference to FIGS. 59 and 60, the exemplary fluidinjection system 600 utilizes the illuminated identification pattern andimage processing techniques discussed herein. As described above, thesystem 600 includes a fluid injector 10 similar to the fluid injectordescribed with reference to FIG. 1. The fluid injector 10 is configuredto engage a pair of syringes 12. The syringes 12 are mounted to syringeports 16 of the fluid injector 10. A number of electromagnetic radiationsources 112, such as LEDs, are mounted to or embedded in a distal end ofa piston rod 124 of the injector 10. The LEDs are configured toilluminate in a first color when a first fluid is detected within thesyringe 12 and a second color when a second fluid is detected within thesyringe 12. When actuated, the piston rod 124 advances toward and isreceived within the cavity (not shown) defined by the plunger 26. TheLEDs emit light in the axial direction through the plunger cover 26 forproducing the halo 120 adjacent to the distal end 24 of the syringebarrel 18 in the manner discussed above. The sensor 114 may be removablyprovided on a support portion 602 of the fluid injection system 600 suchthat the sensor 114 is positioned behind the syringes 12 when thesyringes 12 are being filled with fluid from a multi-dose fluid bottleor bag. As described herein, the fluid injection system 600 may beconfigured to identify the type of fluid that is directed into thesyringe 12 or the fluid level in each syringe 12 using image processingtechniques. Based on the information identified by the imaginingprocessing techniques, the injector 10 may adjust its operatingparameters to achieve desired filling and injection parameters.

As discussed herein, the electromagnetic radiation source 112 may be alight bulb, LED bulb, visible light emitter, infrared emitter, or laser,positioned to project an electromagnetic radiation beam through aninterior of the syringe 12. The electromagnetic radiation source emitselectromagnetic radiation generally in an axial direction through thesyringe 12. For example, an electromagnetic radiation beam may passthrough a translucent or transparent plunger or plunger cover 26 andtoward the distal end 24 of the syringe 12.

As discussed in greater detail herein, the electromagnetic radiationsource 112 can be configured to increase conspicuousness of the halo 120or to tailor the halo 120 for particular sensors or electromagneticradiation detectors. In one example, the electromagnetic radiationsource 112 includes a laser having a wavelength of about 532 nm (e.g., agreen laser). The green laser electromagnetic radiation source can beused with neutral colored or transparent plungers and still produce aconspicuous colored halo. In other examples, the electromagneticradiation source 112 can emit electromagnetic radiation outside thevisible spectrum provided that the system includes a sensor or cameracapable of detecting radiation (e.g., the halo) within the emittedwavelength. In one such aspect, an infrared sensor may be provided todetect the radiation on the syringe 12. In still other examples, theelectromagnetic radiation source can be configured to emit polarizedlight or certain wavelengths of filtered light, which can be more easilydistinguished from ambient light. In other examples, the electromagneticradiation source can be configured to emit pulses of light according toa predetermined and identifiable sequence, which can be identified by asystem operator or automatically detected by a sensor.

Light or electromagnetic radiation passing through the plunger orplunger cover 26 substantially radiates through the syringe 12 to formthe halo 120. When the syringe 12 is empty or only partially filled, theelectromagnetic radiation beams pass through the syringe 12, but do notform a distinctive illuminated portion or halo near the distal endthereof as shown in FIG. 8. In contrast, when the syringe 12 is entirelyfilled with fluid, the electromagnetic radiation beams are refracted bythe fluid, which produces a halo 120 near the distal end 24 of thesyringe 12. A system operator or automated image reading or opticaldevice, such as sensor 114, can identify whether the halo, if present,is the correct shape and size. If the halo is too small, not brightenough, or not present at all, the system operator can add additionalfluid to the syringe 12 for complete filling. If a halo having thecorrect size, shape, and brightness is identified, then verification iscomplete and the fluid contents of the syringe 12 are ready foradministration to a patient.

In certain examples, the system 600 is also capable of, through the useof image recognition, determining whether two syringes 12 are present onthe fluid injector 10 simultaneously. In addition, the system 600detects whether the syringes 12 are filled with fluid or air. The system600 also, using images obtained from sensor 114, visualizes features onthe syringe barrel 18, visualizes height differences of the halo 120, orvisualizes laser light passing through the fluid to detect which of thetwo syringes 12 has contrast and which has saline as described ingreater detail herein. Once this has been determined, the system 600 cansend a signal to the electromagnetic radiation source 112 positioned onthe piston rod 124 underneath the translucent plungers on the injectorhead. This signal can alert the electromagnetic radiation source tolight up the LEDs in a first color, such as green, underneath syringe 12determined to have contrast, and light up the LEDs in a second color,such as blue, underneath syringe 12 determined to have saline. Thislight will illuminate halo 120 to have a color corresponding to that ofthe LEDs, for visualization by the operator.

The system can also send a signal to alert the operator of the type offluid via any other method of visual, auditory, or sensory cues. Forinstance, once it has been determined by image recognition techniquesthat a syringe 12 contains contrast, visual cues (LEDs, laser light,graphics, and/or text) and/or auditory cues (alarms, bells, whistles,other sounds) alerts the operator to the fact that a particular syringe12 contains contrast. For example, green overlay features may be usedfor the side of the injector 10 specified for contrast. Green LEDs canbe used to illuminate the halo 120 on the syringe 12 that has beendetermined to have contrast, regardless of which side the syringe 12 ison. This will be achieved by having circuits of both LED colors (greenand blue) where the green will be illuminated if contrast is determinedto be present and blue if saline is determined to be present. It is alsopossible to send messages to the operator in the control room alertingthem to which syringe is on which side, and whether that conflicts withthe protocol prescribed by the attending physician.

With specific reference to FIG. 59, the system 600 has determined that acontrast syringe 12 a is installed at right and a saline syringe 12 b atleft as shown. On the display 118, “C” is displayed at right and “S” atleft to indicate that the image processing software of the centralprocessing unit 116 has identified contents of syringe at left as salineand contents of syringe at right as contrast. With reference to FIG. 61,the contrast syringe 12 a has been moved to the left position and salinesyringe 12 b to the right position as shown. On the display 118, “C” isnow displayed at the left and “S” is now displayed at the right toindicate that the image processing software of the central processingunit 116 has identified contents of syringe at left as contrast andcontents of syringe at right as saline. With reference to FIG. 62, thefluid injector 10 is shown with the syringes 12 a, 12 b absent. On thedisplay 118, “A” is now displayed at both left and right to indicatethat the image processing software of the central processing unit 116has identified air present at both locations. With reference to FIG. 63,an empty syringe 12 has been installed at the left position and anotherempty syringe 12 has been installed at right position as shown. On thedisplay 118, “A” is now displayed at both left and right to indicatethat the image processing software of the central processing unit 116has identified air present in both syringes.

O. Utilizing a Syringe with Floating Elements

With reference to FIG. 64, another alternative example of a syringe 12that may be used with fluid injector 10 and fluid verification system110 to determine the type of fluid within the syringe 12 is illustrated.This syringe 12 is similar to the syringe 12 of FIG. 2 except that itincludes a plurality of objects, such as floating balls 650 a, 650 b,and 650 c, positioned between the distal end 24 of the syringe 12 andthe plunger. The density of the balls 650 a, 650 b, and 650 c aredifferent to allow the ball 650 b to float in saline (density equal toor less than 1.0 g/ml) and the ball 650 c to sink in saline but float incontrast (density greater than 1.1 g/ml but less than least densecontrast).

The floating balls 650 a, 650 b, and 650 c for contrast and salinedifferentiation operate based on the principle of buoyancy. This is anupward force on an object in fluid opposing its weight downward. Thedriving variable of this phenomenon is density, specifically of thefluid and of the weight immersed in the fluid. If the density of theballs 650 a, 650 b, and 650 c is greater than that of the fluid byenough margin, the weight overcomes the buoyant force and the balls 650a, 650 b, 650 c sink to the bottom. If the density of the balls 650 a,650 b, 650 c is less by enough margin, the ball 650 a, 650 b, 650 cfloat.

Saline and contrast have different densities. For example, saline mayhave a density around 1 g/mL, while the thicker contrasts have densitiesaround 17 g/mL). In one example, ball 650 b has a density of 0.5 g/mLand ball 650 c has a density of 5 g/mL. With reference to FIG. 65, whenthe syringe 12 is full of air and positioned upright all of the floatingballs 650 a, 650 b, and 650 c sit at the bottom of the syringe 12 due togravity. Accordingly, a syringe 12 filled with air has no balls floatingnear the distal end 24 thereof. With reference to FIG. 66, when thesyringe 12 is filled with saline, based on the principle describedabove, the ball of density 0.5 g/mL (i.e., ball 650 b) floats to thedistal end 24 of the syringe 12, while the ball of density 5 g/mL (ball650 c) remains at the bottom as the buoyant force does not overcome itsweight. A reference ball 650 a may also be positioned within the syringe12 having a density of less than 0.5 g/mL. This ball 650 a also floatsto the distal end 24 of the syringe 12 when saline is present within thesyringe 12. Accordingly, a syringe 12 filled with saline has two ballsfloating near the distal end 24 thereof. With reference to FIG. 67, whensyringe 12 is filled with contrast of density 17 g/mL, all three balls650 a, 650 b, 650 c float to the top as each ball has a density lessthan the fluid in which they are immersed.

With continued reference to FIGS. 65-67, the sensor 114 may bepositioned to capture an image of the distal end 24 of the syringe 12.Thereafter, the image processing software on the central processing unit116 can detect the presence or absence of the balls 650 a, 650 b, and650 c in the image. If the image processing software on the centralprocessing unit 116 determines that no balls are present, a signal canbe sent to the display 118 to display that air is present within thesyringe 12. If the image processing software on the central processingunit 116 determines that balls 650 a and 650 b are present, a signal canbe sent to the display 118 to display that saline is present within thesyringe 12. Finally, if the image processing software on the centralprocessing unit 116 determines that all three balls are present, asignal can be sent to the display 118 to display that contrast ispresent within the syringe. This principle works for any number of ballsin the syringe as long as they have the proper corresponding densities.A more in-depth application is having several different balls of varyingdensities that correspond to the varying densities of different brandsand concentrations of contrast. This principle can then be used todetermine the different types of contrast present using imagerecognition of floating balls. In addition, the balls 650 a, 650 b, and650 c may have different sizes to provide another characteristic toallow the image processing software to differentiate between contrastand saline.

The syringe 12 of FIG. 64 may also be utilized to determine atemperature of a fluid contained within the syringe 12. The floatingballs 650 a, 650 b, and 650 c for temperature determination againoperate based on the principle of buoyancy. This is an upward force onan object in fluid opposing its weight downward. The driving variable ofthis phenomenon is density, specifically of the fluid and of the weightimmersed in the fluid. If the density of the balls 650 a, 650 b, and 650c is greater than that of the fluid by enough margin, the weightovercomes the buoyant force and the balls 650 a, 650 b, and 650 c sinkto the bottom. If the density of the balls 650 a, 650 b, and 650 c isless by enough margin, the balls float. In this application, densitychanges with temperature. As a fluid contained within the syringe 12 isheated, its volume tends to increase which decreases its density.Accordingly, the floating balls 650 a, 650 b, and 650 c may haveincremental densities (e.g., 0.5 g/mL, 0.6 g/mL, 0.7 g/mL for saline and15 g/mL, 15.5 g/mL, 16 g/mL for contrast) so that as the temperature ofthe fluid is increased, the corresponding decrease in density will causespecific balls 650 a, 650 b, and 650 c to either float or sink. Thedistal end 24 of the syringe 12 may be imaged using the sensor 114 andthe image processing software on the central processing unit 116 candetermine the number of balls present in the image. Once the number ofballs is determined, the central processing unit 116 can correlate thenumber of balls to the temperature of the fluid. The diameter of theballs 650 a, 650 b, and 650 c may also be varied to correspond withtheir density/temperature relationship so that the image processingsoftware on the central processing unit 116 can measure the diameter andcorrelate that to a density and from the density to a temperature of thefluid.

The syringe 12 of FIG. 64 may also be utilized as a pressure limitingtool. More specifically, one of the balls 650 a, 650 b, and 650 c may beconfigured to have a lightly positive buoyancy at zero pressure whensubmerged in a fluid. Accordingly, such a ball floats when the syringeis not injecting fluid and is filled with fluid. As the injectionbegins, the pressure inside the syringe increases. Since the air in thefloating ball is more compressible than the fluid contained within thesyringe, the volume of the ball decreases, thereby increasing itsdensity. Therefore, the floating balls can be designed to sink at aparticular internal pressure within the syringe. For example, the ballcould be designed to drop to the bottom of the syringe at pressuresgreater than 325 psi. The dropping ball is then captured in images takenby the sensor 114 and detected by the image processing software. Asignal is then sent to the fluid injector to limit the pressure of theinjection.

III. Other Concepts

In another example, the source 112 can emit light of a given wavelengthand the speed at which the light travels through the syringe can bemeasured by a detector and processor and is indicative of the type offluid contained within the syringe 12.

It should be noted that while all of the concepts described herein aredescribed with reference to syringes and fluid injectors, this is not tobe construed as limiting the present invention as these concepts may beutilized with any fluid container. For example, these concepts may beutilized in a beverage bottling setting to ensure that each bottle thatis manufactured includes the correct volume of liquid and the correctliquid. The bottles may be provided with a colored translucent ortransparent bottom and an angled neck. After the bottles are filled, anelectromagnetic radiation source is positioned beneath the bottles toprovide light through the bottles and generate a halo near the neck ofthe bottles. This halo can be identified using a sensor and imageprocessing software as described herein. If the halo is absent or animproper size, a signal is generated that the bottle was not properlyfilled.

Although the disclosure has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the disclosure is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements. For example, it is to beunderstood that the present disclosure contemplates that, to the extentpossible, one or more features of any embodiment can be combined withone or more features of any other embodiment.

The invention claimed is:
 1. A method for syringe fluid fillverification comprising: shining incident electromagnetic radiation onat least a portion of a distal surface of a plunger slidably disposed ina barrel of the syringe; identifying whether at least a portion of theelectromagnetic radiation produces an illuminated identification patternon a predetermined portion of the syringe; and determining a presence ofthe illuminated identification pattern, wherein the presence of theilluminated identification pattern indicates that the syringe is filledwith a medical fluid and less than 5 mL of air, wherein the at least theportion of the distal surface of the plunger is tinted a conspicuouscolor so that at least a portion of the incident electromagneticradiation is reflected off the at least the portion of the distalsurface to produce the illuminated identification pattern.
 2. The methodof claim 1, wherein identifying whether the at least the portion of theelectromagnetic radiation produces the illuminated identificationpattern comprises measuring at least one property of the illuminatedidentification pattern by at least one sensor associated with thesyringe; and receiving a confirmation signal from the at least onesensor indicating a value for the at least one property of theilluminated identification pattern.
 3. The method of claim 2, whereinthe at least one property is at least one of the presence of theilluminated identification pattern, a size of the illuminatedidentification pattern, a shape of the illuminated identificationpattern, and a brightness of the illuminated identification pattern. 4.The method of claim 1, wherein emitting electromagnetic radiationthrough at least a portion of the syringe comprises emittingelectromagnetic radiation through a syringe plunger, at least a portionof which comprises a transparent or translucent material.
 5. The methodof claim 1, wherein the illuminated identification pattern is of thesame conspicuous color as the at least the portion of the distal surfaceof the plunger.
 6. The method of claim 5, wherein the illuminatedidentification pattern comprises a halo formed at the predeterminedportion of the syringe and wherein there predetermined portion of thesyringe is a tapered, conical surface of a distal end of the syringe. 7.The method of claim 1, further comprising halting an injection procedureif the illuminated identification pattern is not observed at thepredetermined portion of the syringe.
 8. The method of claim 1, furthercomprising determining contents of the syringe by determining a type offluid contained within the syringe.
 9. The method of claim 8, whereinthe type of fluid contained within the syringe is determined by a sizeof the illuminated identification pattern at a tapered, conical surfaceof a distal end of the syringe.
 10. The method of claim 8, wherein thetype of fluid is selected from an imaging contrast agent and saline. 11.A method for checking for the presence of air in a syringe, the methodcomprising: emitting electromagnetic radiation through at least aportion of the syringe; identifying whether at least a portion of theelectromagnetic radiation produces an illuminated identification patternon at least a portion of a tapered, conical surface of a distal end ofthe syringe; and determining if greater than 5 mL of air is present inthe syringe based on whether the illuminated identification pattern isobserved at the tapered, conical surface of the distal end of thesyringe.
 12. The method of claim 11, further comprising halting aninjection procedure if the illuminated identification pattern is notobserved at the tapered, conical surface of the distal end of thesyringe.
 13. The method of claim 11, wherein emitting electromagneticradiation through the at least the portion of the syringe comprisesshining incident electromagnetic radiation through a sidewall of thesyringe onto at least a portion of a distal surface of a plunger,wherein the plunger is slidably disposed within a barrel of the syringe.14. The method of claim 13, wherein the at least the portion of thedistal surface of the plunger is tinted a conspicuous color.
 15. Themethod of claim 14, wherein the conspicuous color is orange.
 16. Themethod of claim 14, wherein the illuminated identification pattern is ahalo of the conspicuous color on the at least the portion of thetapered, conical surface of the distal end of the syringe.
 17. Themethod of claim 11, wherein emitting electromagnetic radiation throughat least the portion of a syringe comprises emitting electromagneticradiation through a transparent or translucent portion of a plungerslidably disposed within the syringe.
 18. The method of claim 17,wherein a distal end of a piston of a fluid injector comprises at leastone light source to emit electromagnetic radiation through thetransparent or translucent portion of the plunger.
 19. The method ofclaim 11, wherein emitting electromagnetic radiation through at leastthe portion of a syringe comprises emitting electromagnetic radiationthrough a proximal end wall of the syringe.